Page 1 Owner’s booklet. Get to know your system.
Page 3: Welcome And Congratulations
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.
Page 4: Table Of Contents
VIBE INSULIN PUMP SECTION I : ® ™ CHAPTER 1 - Insulin Pump Overview CHAPTER 2 - Introduction to your Animas Vibe Insulin Pump ® ™ CHAPTER 3 - Getting your pump ready CHAPTER 4 - Using the Normal Bolus feature...
Page 5 CHAPTER 2 - Lens protection film application instructions CHAPTER 3 - Troubleshooting guidelines CHAPTER 4 - Sick day guidelines CHAPTER 5 - Lifestyle issues CHAPTER 6 - My information CHAPTER 7 - Warranty and other technical information Appendix A: Glossary Index Animas Distributor Contact Information...
Page 6 • 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 ™...
Page 7: Intended Use
Animas Vibe System is also a glucose-monitoring device indicated for detecting trends and tracking ® ™ patterns in adults (age 18 and older) with diabetes. The Animas ® Vibe ™ System is intended for use by patients at home and in health care facilities.
Page 8 Animas Vibe System ® ™ Read the entire Section I and Section II 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.
Page 9: Involving Use Of Medical Procedures
System During Medical ® ™ Procedures 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.
Page 10 BEFO R E YOU BEG I N Medical Procedure Device User (Patient or HCP administering the procedure) Do Not bring pump or CGM Transmitter/Sensor into the same room • where the procedure is being performed. PACEMAKER/AICD Reprograming Teﬂon/plastic infusion set can remain in. Other types of infusion sets •...
Page 11 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.
Page 12 BEFO R E YOU BEG I N PRECAUTIONS (continued) • Y our 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.
Page 13 Call Customer Support or your local Animas distributor if you identify or suspect your pump has been damaged. In the United Kingdom, call (free phone) 0800 055 6606. In Ireland, call 1 800 812 715.
Page 14 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.
Page 15 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 II refer to the Animas Vibe Insulin ®...
Page 16 BEFO R E YOU BEG I N 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.
Page 17 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).
Page 18: Explanation Of Symbols
BEFO R E YOU BEG I N Explanation of symbols Shown below are symbols you will ﬁnd on your Animas ® Vibe ™ Insulin Pump and its packaging. On your pump kit packaging: Do Not Reuse Pressure Limitations Fragile Relative Humidity Limitations...
Page 19 BEFO R E YOU BEG I N 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. “...
Page 20: Emergency Kit
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).
Page 21: Section I
Section I Animas Vibe ® ™ Insulin Pump...
Page 23: Chapter 1 - Insulin Pump Overview
If there is anything you do not understand 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).
Page 24 Replacement films can be purchased 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).
Page 25: Display Screen
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.
Page 26: Chapter 2 - Introduction To Your Animas ® Vibe ™ Insulin Pump
CHAP TER 2 - I NTRO D U CTI ON TO Y OU R AN IM AS VIBE INSUL IN P UMP ® ™ Contrast Button/CGM Shortcut Pressing this button adjusts the contrast of your display. There are three contrast levels: Dim, Default and Bright.
Page 27 CHA PTER 2 - I NTROD U CT ION TO YOU R A NIM AS VIBE IN SULIN PUM P ® ™ Battery Cap/Vent This cap unscrews easily with a coin to replace and secure your battery. There is an o-ring around the cap, which prevents water from entering the pump.
Page 28: Home Screen
CHAP TER 2 - I NTRO D U CTI ON TO Y OU R AN IM AS VIBE INSUL IN P UMP ® ™ Tamper 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 buttons at the same time until the screen reads “(LOCKED)
Page 29: Main Menu Screen
CHA PTER 2 - I NTROD U CT ION TO YOU R A NIM AS VIBE IN SULIN PUM P ® ™ Main Menu Screen MAIN MENU Bolus This screen shows all Main Menu options. Suspnd/Resum History Bolus Basal Setup Prime/Rewind This selection takes you to the Normal Bolus screen.
Page 30 CHAP TER 2 - I NTRO D U CTI ON TO Y OU R AN IM AS VIBE INSUL IN P UMP ® ™...
Page 31: Chapter 3 - Getting Your Pump Ready
CHAPTER 3 - GETTING YOUR PUMP READY WARNING: Before proceeding with this chapter, you should have completed your pump training. To complete this section, you will need the following items: • Animas Vibe Insulin Pump ® ™ • Energizer Lithium Ultimate AA battery (1.5V) ®...
Page 32: Changing The Battery
CHAP TER 3 - G ETTI N G Y O U R PU M P READ Y Changing the Battery Each time you change the battery • Always disconnect from infusion site prior to changing the battery. • A full rewind and prime sequence is required. See Priming your Pump and Infusion Set, pages 16-18 in this chapter.
Page 33: Setting/Changing Time And Date
CHA PTER 3 - GETTI NG Y OU R PU MP READ Y Check the displayed time/date, battery type and language. If correct, scroll 2 : 27 down to highlight “Conﬁrm” and press the button. The Home screen will be displayed.
Page 34: Spring Forward/Fall Back
CHAP TER 3 - G ETTI N G Y O U R PU M P READ Y Use the buttons to change to your desired settings. Press the SETUP Time/Date button to conﬁrm your setting and exit Edit mode. Hour: Minute 2: 27PM Use the buttons to select the next ﬁeld.
Page 35 CHA PTER 3 - GETTI NG Y OU R PU MP READ Y The options from the ﬁrst SETUP SOUND menu are listed below. Normal Bolus Sound and Temp Basal Sound can be set to one of the following: Vibrate (Vib), Low volume (L) , Medium volume (M) , High volume (H) or can be shut off (OFF) completely.
Page 36: The Cartridge
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 ®...
Page 37 CHA PTER 3 - GETTI NG Y OU R PU MP READ Y Remove cap from the ﬁlled cartridge tip. To Connect infusion set to avoid insulin spillage and introduction of air in cartridge here the cartridge, it should never be ﬁlled beyond the 2.0 mL mark.
Page 38 CHAP TER 3 - G ETTI N G Y O U R PU M P READ Y 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.
Page 39 CHA PTER 3 - GETTI NG Y OU R PU MP READ Y Insert your ﬁlled cartridge. Secure cartridge compartment cap to pump by turning in a clockwise motion until ﬁnger tight but Do Not over tighten. 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.
Page 40 CHAP TER 3 - G ETTI N G Y O U R PU M P READ Y Make sure “Go Prime” is highlighted. Press PRIMING PRIMING ACTIVE DONE and hold the button until you see 5 drops of Press AND HOLD insulin come out the end of your infusion set.
Page 41: Selecting The Infusion Site And Inserting The Infusion Set
CHA PTER 3 - GETTI NG Y OU R PU MP READ Y 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 Instructions For Use included with your infusion set for proper insertion guidelines.
Page 42 CHAP TER 3 - G ETTI N G Y O U R PU M P READ Y...
Page 43: Chapter 4 - Using The Normal Bolus Feature
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 I, pages 43-56. MAIN MENU From the MAIN MENU, select “Bolus”.
Page 44 CHAP TER 4 - USI NG TH E N ORM AL BOL U S FE ATU RE 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” Normal ezCarb from the MAIN MENU.
Page 45: Chapter 5 - Using Basal Program Features
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 meals. 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.
Page 46 CHAP TER 5 - USI NG BASAL P ROGR AM F EATU RES Scroll to select the program “1-WEEKDAY” and press BASAL MENU Total 0.00U Temp NOTE: You do not have to Suspend your pump to edit an active program. A1-WEEKDAY When you select “Edit”...
Page 47 CHA PTER 5 - US I N G BASA L PRO GRAM F EATU RES Continue until basal segments have been set as recommended by your health care team. When ﬁnished, scroll to “Save/Review” and press . If you have edited the active program, it is now resumed automatically.
Page 48: Reviewing Basal Programs
CHAP TER 5 - USI NG BASAL P ROGR AM F EATU RES NOTE: • If you program a segment to start at the same time as an existing segment, the previously entered segment is deleted. • If you program a segment to start at a time that precedes an existing segment, the new segment is automatically inserted in the correct place.
Page 49: Temporary Basal Feature
CHA PTER 5 - US I N G BASA L PRO GRAM F EATU RES Clearing Basal Programs BASAL OPTIONS A1-WEEKDAY Total This feature allows you to clear all information from a basal program. 13.60U Clear From the BASAL MENU, scroll to desired program. Edit Review Main Menu...
Page 50 CHAP TER 5 - USI NG BASAL P ROGR AM F EATU RES The “Change” % ﬁeld will ﬂash to indicate A1-WEEKDAY A1-WEEKDAY TEMP BASAL TEMP BASAL Edit mode. Use the buttons to enter the percentage change desired. Press the button to Change: Change:...
Page 51: Canceling A Temporary Basal Program
CHA PTER 5 - US I N G BASA L PRO GRAM F EATU RES Canceling a Temporary Basal Program From the BASAL MENU, select “TEMP BASAL”. Press A1-WEEKDAY Details of the current active Temp Basal program will be displayed. Scroll TEMP ACTIVE 0.675 U/Hr up to “CANCEL”...
Page 52 CHAP TER 5 - USI NG BASAL P ROGR AM F EATU RES...
Page 53: Chapter 6 - Suspend/Resume Feature
CHAPTER 6 - SUSPEND/RESUME FEATURE 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 I, pages 43-56. Suspending Delivery From the MAIN MENU, scroll to “Suspnd/Resum”...
Page 54: Resuming Delivery
CHAP TER 6 - S US PEN D /RES UM E FE ATU RE 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.
Page 55: Chapter 7 - History Feature
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 II, pages 119-122. Your pump stores basal rates, boluses, alarms and settings. Your pump stores these records indeﬁnitely, even when batteries are removed.
Page 56 CHAP TER 7 - HI STORY F EATU RE Record 1 indicates the most recent record. Use the buttons to scroll to other records. When ﬁnished reviewing, press to exit Review Mode. “ ” is highlighted. Press to return to the HISTORY menu. Total Daily Dose (TDD) History Your pump displays the last 120 TDD records.
Page 57: Prime History
CHA PTER 7 - HI STO RY F EAT U 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).
Page 58 CHAP TER 7 - HI STORY F EATU RE Record 1 indicates the most recent record. Use the buttons PRIME to scroll to other records. Record 23 Mar, 2010 The screen displays the following: 01:15PM Fill Cannula • Record number Total 1.0U •...
Page 59: Basal History
CHA PTER 7 - HI STO RY F EAT U RE 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. HISTORY BASAL From the HISTORY menu, select “Basal”.
Page 60 CHAP TER 7 - HI STORY F EATU RE...
Page 61: Chapter 8 - Status Feature
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. From the MAIN MENU or from the Home screen, scroll to “Status” and press MAIN MENU 2 : 27 Bolus...
Page 62 CHAP TER 8 - S TATU S F EATU RE 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 U100 Temp •...
Page 63 STATUS 7 CODES The screen contains information that will be useful to Customer Support or — XX — XX — XX — XX your local Animas distributor (see page 187) if requested. X XX XX Y XX XX Z XX XX To move to the next STATUS screen, press with “...
Page 64 CHAP TER 8 - S TATU S F EATU RE...
Page 65: Chapter 9 - Advanced Features/Setup And Activation
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.
Page 66 CHAP TER 9 - A DVAN CED F EAT U RES / SET U P AN D A CTIVATION To move to the next I:C Ratio screen, scroll to “ ” and press I:C Ratio 2 of 12 Time: Scroll up to the “Time” ﬁeld and press to change to ﬂashing cursor 6:00A for Edit Mode.
Page 67 CHA PTER 9 - ADVA NCE D F EATU RES / SET UP AN D A CTIVATION Scroll up to the “Time” ﬁeld and press to change to ﬂashing cursor for 2 of 12 Edit mode. Time: 6:00A Use the buttons to change the segment start time.
Page 68 CHAP TER 9 - A DVAN CED F EAT U RES / SET U P AN D A CTIVATION If you set a BG Target range, then the difference between your current BG and your BG Target range is determined as follows: •...
Page 69 CHA PTER 9 - ADVA NCE D F EATU RES / SET UP AN D A CTIVATION 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 (range or value) is set by ﬁrst selecting a BG Target and then a +/- amount that will deﬁne the minimum and maximum of the range.
Page 70 CHAP TER 9 - A DVAN CED F EAT U RES / SET U P AN D A CTIVATION 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.
Page 71 CHA PTER 9 - ADVA NCE D F EATU RES / SET UP AN D A CTIVATION 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.
Page 72: Battery Type
CHAP TER 9 - A DVAN CED F EAT U RES / SET U P AN D A CTIVATION 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: SETUP ADV 4 Language...
Page 73 CHA PTER 9 - ADVA NCE D F EATU RES / SET UP AN D A CTIVATION 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.
Page 74 CHAP TER 9 - A DVAN CED F EAT U RES / SET U P AN D A CTIVATION NOTE: Warning • T he 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 20U, it will cartridge.
Page 75 CHA PTER 9 - ADVA NCE D F EATU RES / SET UP AN D A CTIVATION 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.
Page 76 CHAP TER 9 - A DVAN CED F EAT U RES / SET U P AN D A CTIVATION WARNING: The IOB feature is intended for use only with U100 rapid-acting insulin analogs such as Novo Rapid , NovoLog , Humalog , or Apidra .
Page 77 CHA PTER 9 - ADVA NCE D F EATU RES / SET UP AN D A CTIVATION 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.
Page 78 CHAP TER 9 - A DVAN CED F EAT U RES / SET U P AN D A CTIVATION...
Page 79: Chapter 10 - Using Advanced Features
CHAPT ER 10 - U SIN G AD VANCED FEAT UR ES 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 your basal rates and your health care team has determined your individual targets and ratios.
Page 80 CHAP TER 1 0 - USI N G AD VAN CED F EATU RES Within 5 seconds, your pump will beep twice to “ask” you to conﬁrm that Audio Bolus you wish to activate delivery and “Conﬁrm” is displayed on the Audio Bolus screen.
Page 81 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.
Page 82 • 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 0g (grams). This refers to carb amounts that are entered from the “Food List” option, which is not yet operational with the Animas Vibe Insulin ®...
Page 83 CHA PTER 1 0 - US IN G AD VAN CED FEA TU RES The Bolus Total screen is displayed and the suggested (calculated) bolus Bolus Total amount from your ezCarb Bolus appears in the “Total” ﬁeld. Above the “Total” Carb 2.26U 0.00U...
Page 84 Always verify BG levels with a BG meter. • 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.
Page 85 CHA PTER 1 0 - US IN G AD VAN CED FEA TU RES The Bolus Total screen is displayed and the suggested (calculated) bolus Bolus Total amount from your ezCarb Bolus appears in the “Total” ﬁeld. Above the “Total” Carb 2.26U 2.70U...
Page 86 CHAP TER 1 0 - USI N G AD VAN CED F EATU RES ezCarb Examples with the IOB Feature Activated If the IOB feature is activated, your IOB amount will be displayed for reference on the ezCarb Bolus Total screen. With the IOB feature activated, your suggested ezCarb total bolus amount will be as follows: •...
Page 87 CHA PTER 1 0 - US IN G AD VAN CED FEA TU RES 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 Normal ezCarb Target range for the current time stored in the pump.
Page 88 CHAP TER 1 0 - USI N G AD VAN CED F EATU RES The ezBG Total screen is displayed and the suggested bolus amount from ezBG Total your ezBG Bolus appears in the “Total” ﬁeld. Above the “Total” ﬁeld are the 2.81U - -.- - U two parts that are used in calculating the suggested “Total”...
Page 89 CHA PTER 1 0 - US IN G AD VAN CED FEA TU RES ezBG Examples with the IOB Feature Activated If the IOB feature is activated, your IOB 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: •...
Page 90: Combo Bolus
CHAP TER 1 0 - USI N G AD VAN CED F EATU RES 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.
Page 91: Reminders
CHA PTER 1 0 - US IN G AD VAN CED FEA TU RES Scroll to “Go” and press to activate. The Home Combo Bolus 2 : 27 Total screen shows Combo Bolus Active. 8.50U Duration 4.0Hr BOLUS ACTIVE Normal: Extend Basal Rate 0.675U/Hr...
Page 92: Bg Check Reminder
CHAP TER 1 0 - USI N G AD VAN CED F EATU RES The “Time” ﬁeld for this reminder will be highlighted. Press to activate REMINDERS Edit mode. Use the buttons to enter the time you wish a reminder to Reminder-1 Time = 12:00...
Page 93 CHA PTER 1 0 - US IN G AD VAN CED FEA TU RES NOTE: When you enter a time, your pump will sound a reminder and display Reminder this screen at that time after any Normal Bolus or Audio Bolus is delivered, Check including the Normal portion of a Combo Bolus.
Page 94 CHAP TER 1 0 - USI N G AD VAN CED F EATU RES 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 III, pages 157-158, and contact your health care team. SETUP ADV 9 Sick Days From the SETUP menu, select “Advanced”.
Page 95: Chapter 11 - Pump Safety System And Alarms 7
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.
Page 96 CHAP TER 1 1 - P UMP SAF ETY SY ST EM AN D AL AR M S Alerts, Warnings and Alarms Alert Alert: Active Basal Program Empty Your active basal Cause Active basal program is empty. program is empty. 0.000U/Hr Effect No basal deliveries.
Page 97 CHAP TER 1 1 - PUM P SAF ET Y SY ST EM AND AL ARM S Alerts, Warnings and Alarms Alert Alert: Low BG LOW BG Cause BG entry below 3.9 mmol/L. Treat low BG. No bolus Effect recommended. Requires user conﬁrmation to continue.
Page 98 CHAP TER 1 1 - P UMP SAF ETY SY ST EM AN D AL AR M S Alerts, Warnings and Alarms Alert Alert: Clear Program Basal Segments Clear Program Cause Clear command selected from BASAL OPTIONS screen. deletes all basal segments in this program.
Page 99 CHAP TER 1 1 - PUM P SAF ET Y SY ST EM AND AL ARM S Alerts, Warnings and Alarms Warning Warning: Suspend No delivery. Cause Pump suspended manually. Pump is suspended. Effect All insulin deliveries stop. Confirm Displayed each time pump is awakened until conﬁrmed Message and once every 15 minutes until action is taken.
Page 100 CHAP TER 1 1 - P UMP SAF ETY SY ST EM AN D AL AR M S Alerts, Warnings and Alarms Warning Warning: Low Battery Cause Battery life will last a minimum of 30 minutes. battery. Effect Insulin deliveries continue. Confirm Displays when pump is awake until conﬁrmed.
Page 101 CHAP TER 1 1 - PUM P SAF ET Y SY ST EM AND AL ARM S Alerts, Warnings and Alarms Warning Warning: Exceeds Max TDD Exceeds max TDD XXX U. Bolus delivery exceeds user-set maximum Total Daily No delivery. Cause Dose (TDD).
Page 102 CHAP TER 1 1 - P UMP SAF ETY SY ST EM AN D AL AR M S Alerts, Warnings and Alarms Warning Warning: Exceeds Max Basal Exceeds max basal Basal delivery rate (or Temp Basal delivery) exceeds XXX U/Hr. Cause user-set maximum.
Page 103 CHAP TER 1 1 - PUM P SAF ET Y SY ST EM AND AL ARM S Alerts, Warnings and Alarms Warning Warning: Bolus Delivery Canceled Bolus delivery canceled by User pressed function button on pump during bolus Cause user button delivery.
Page 104 CHAP TER 1 1 - P UMP SAF ETY SY ST EM AN D AL AR M S Alerts, Warnings and Alarms ALARM Alarm: Empty Cartridge EMPTY CARTRIDGE Cause Cartridge empty. No delivery. Replace cartridge. Effect All insulin deliveries stop. Suspend Confirm Message...
Page 105 Animas distributor. In the United Kingdom, call Action (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, Beeps/Vib progresses to sweep/vib within one hour.
Page 106 CHAP TER 1 1 - P UMP SAF ETY SY ST EM AN D AL AR M S...
Page 107 Section II Continuous Glucose Monitoring (CGM)
Page 109: Chapter 1 - Cgm Overview
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.
Page 110 CHAPTER 1 - CG M OVERVI EW...
Page 111: Chapter 2 - Cgm Settings
CHAPT ER 2 - C GM SE T TI NGS 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.
Page 112 CHAPT ER 2 - CG M SETTI N GS Scroll to the “S/N#” ﬁeld. The last digit will be highlighted. Scroll to the Transmitter ﬁrst digit and then press so that the ﬁrst digit is ﬂashing. NOTE: 0 0 0 0 •...
Page 113 CHA PTER 2 - CGM S ETTI N GS Setting CGM Alerts on your Pump You can set your pump to display and sound (beep/vibrate) an alert when: • Your CGM readings are outside your target range. • Your CGM readings may be rising or falling too quickly. •...
Page 114 CHAPT ER 2 - CG M SETTI N GS CGM Setup Scroll to “Sounds” on the CGM Setup screen and press Sounds High Alert Low Alert Rise Rate Fall Rate Out of Range Transmitter CGM Menu CGM Warning The “High Alert” ﬁeld will be highlighted on the CGM Warning Sounds Sounds screen.
Page 115 CHA PTER 2 - CGM S ETTI N GS 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 From the CGM Setup screen, scroll to “High Alert”.
Page 116 CHAPT ER 2 - CG M SETTI N GS Low Alert Scroll to “Low Alert” on the CGM Setup screen and repeat these steps Warn below for the Low (Glucose) Alert. You may set the Low Alert from 3.3 mmol/L to mmol/L 5.5 mmol/L (default is 4.4 mmol/L) in 0.5 mmol/L increments, the snooze Snooze time...
Page 117 CHA PTER 2 - CGM S ETTI N GS (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)). From the CGM Setup screen, scroll to “Out of Range”.
Page 118 CHAPT ER 2 - CG M SETTI N GS...
Page 119: Chapter 3 - Inserting The Cgm Sensor And Transmitter
CHAPTER 3 - INSERTING THE CGM SENSOR AND TRANSMITTER 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.
Page 120 CHAPT ER 3 - I N SE RTI NG TH E CGM SEN SOR AND TR ANS MITTER 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 Transmitter into the Sensor Pod using the Transmitter Latch.
Page 121 CHA PTE R 3 - I NS ERTI N G TH E CGM SEN SOR AN D TR ANS MITTE R 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...
Page 122 CHAPT ER 3 - I N SE RTI NG TH E CGM SEN SOR AND TR ANS MITTER Choose an insertion site PRECAUTIONS: • 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. •...
Page 123 CHA PTE R 3 - I NS ERTI N G TH E CGM SEN SOR AN D TR ANS MITTE R After placing the CGM Sensor, press ﬁrmly on and around the outside of the adhesive patch to make sure it is ﬂat. •...
Page 124 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). Tape the Sensor Pod The Sensor Pod should stay attached on its own.
Page 125 CHA PTE R 3 - I NS ERTI N G TH E CGM SEN SOR AN D TR ANS MITTE R 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.
Page 126 CHAPT ER 3 - I N SE RTI NG TH E CGM SEN SOR AND TR ANS MITTER...
Page 127: Chapter 4 - Starting A Cgm Session
CHAPTER 4 - STARTING A CGM SESSION 2-Hour CGM Startup Period Once your CGM Sensor is inserted, and your CGM Transmitter ID/Serial Number is 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.
Page 128 • 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).
Page 129 CHAPTER 5 - CGM CALIBRATION In order for your CGM to work properly, you will be prompted 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.
Page 130 CHA PTER 5 - C GM CA L IBRA TIO N 2-Hour CGM Startup Period Calibration When the 2-hour CGM startup period ends, you will be prompted to enter 2 CGM Warning separate ﬁngerstick BG values in your pump. Press to conﬁrm the Warning.
Page 131 CHAPTE R 5 - CGM CAL IB RATI ON CGM Recalibration When you enter a ﬁngerstick BG value for calibration update, the CGM CGM Warning checks how well it is functioning compared to BG meter results. During each calibration update, you may be prompted for another ﬁngerstick BG value. Enter BG You may also be prompted for another ﬁngerstick BG value during the 2-hour startup period.
Page 132 CHA PTER 5 - C GM CA L IBRA TIO N...
Page 133 C HAPTE R 6 - VI EW IN G CGM I NFO RMA TI ON O N Y O UR PU M P Your ﬁngerstick BG meter only gives you a BG level at one point in time (like a still picture). 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).
Page 134 CHAPT E R 6 - VI EW I NG CGM I NF O RM ATIO N ON Y O UR P UM P CGM Data Screen Example CGM Data Screen The CGM Data screen provides a snapshot of your current glucose status. Each CGM Data Trend Arrow screen displays the current time on your pump, Current Time...
Page 135 CHAPT ER 6 - VI EW IN G CGM IN F ORM ATION O N Y OU R PUM P CGM Data and CGM Trend Screen Arrows and Color Key NOTE: The color key applies to the Trend Arrows on the CGM Data and CGM Trend screens, and CGM data points (readings) on the CGM Trend screens.
Page 136 CHAPT E R 6 - VI EW I NG CGM I NF O RM ATIO N ON Y O UR P UM P 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.
Page 137 CHAPT ER 6 - VI EW IN G CGM IN F ORM ATION O N Y OU R PUM P Accessing the CGM Data and CGM Trend screens from the CGM Menu MAIN MENU From the MAIN MENU screen, scroll to “CGM” and press Bolus Suspnd/Resum History...
Page 138 CHAPT E R 6 - VI EW I NG CGM I NF O RM ATIO N ON Y O UR P UM P CGM High/Low and Rise/Fall Rate Alerts The High and Low (Glucose) Alerts let you know when your CGM readings fall outside the levels you set in the pump.
Page 139 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).
Page 140 Warning, call Customer Support or your local Animas distributor for assistance. In the United Kingdom, call (free phone) 0800 055 6606. Confirm In Ireland, call 1 800 812 715. All other countries, call your local Animas CGM Warning distributor (see page 187).
Page 141 CHAPT ER 6 - VI EW IN G CGM IN F ORM ATION O N Y OU R PUM P Missing CGM Readings – appears in place of current CGM reading Any time you see the symbol on either the CGM Data or CGM Trend 12:34 PM screens, your pump requires that you enter a ﬁngerstick BG value for a calibration update or recalibration.
Page 142 CHAPT E R 6 - VI EW I NG CGM I NF O RM ATIO N ON Y O UR P UM P...
Page 143: Chapter 7 - Cgm History Screens
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.
Page 144 CHA PTE R 7 - CGM H ISTO RY SC REEN S CGM Alert If there is no active CGM session, a 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 From the CGM History screen, scroll to “Last BG Cal”.
Page 145 CHA PTER 7 - CG M H IST ORY S CREE N S CGM Alert History This selection displays the date, time, alert code and description of your last 300 CGM alerts. CGM History From the CGM History screen, scroll to “Warnings”. Press Session Start Last BG Cal.
Page 146 CHA PTE R 7 - CGM H ISTO RY SC REEN S...
Page 147 CHAP TE R 8 - C O MPL ET ING A CGM SESSI ON 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.
Page 148 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.
Page 149 CHAP TE R 9 - REM O VIN G T H E CGM T R ANSM I T TE R A ND SENSO R 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).
Page 150 • The CGM 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 055 6606. In Ireland, call 1 800 812 715. All other countries, call your local Animas distributor (see page 187).
Page 151 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. CGM Warning...
Page 152 CHAPTER 1 0 - CG M SAF ET Y SY ST E M A ND AL ERTS CGM Warning Warning: Second BG Value Required For 2-Hour Startup Calibration Enter Only 1 of the 2 required BG values has been entered 1 more of 2 Cause...
Page 153 CHAP TER 1 0 - CG M SAF ETY SY STEM AN D AL ERTS CGM Warning Warning: BG Value Required For Recalibration Enter BG The BG value entered has not been accepted for Cause startup calibration or calibration update. Insulin deliveries continue.
Page 154 CHAPTER 1 0 - CG M SAF ET Y SY ST E M A ND AL ERTS CGM Warning Warning: CGM Session Expires In 6 Hours CGM Session Current CGM Session has 6 hours left until 7-day Cause Expires In period ends.
Page 155 CHAP TER 1 0 - CG M SAF ETY SY STEM AN D AL ERTS CGM Warning Warning: CGM Session Expires In 30 Minutes CGM Session Current CGM Session has 30 minutes left until 7-day Cause Expires In period ends. 00:30 Effect Insulin deliveries continue.
Page 156 CHAPTER 1 0 - CG M SAF ET Y SY ST E M A ND AL ERTS CGM Warning Warning: Glucose Level Above High Glucose Alert Level Glucose Cause Last CGM reading at or above limit set in pump. Level is Above High User Limit Effect...
Page 157 CHAP TER 1 0 - CG M SAF ETY SY STEM AN D AL ERTS CGM Warning Warning: Glucose Level Falling Faster Than Fall Rate Limit Glucose Level is CGM readings are falling at or faster than Fall Rate Cause Falling Too limit set in pump.
Page 158 CHAPTER 1 0 - CG M SAF ET Y SY ST E M A ND AL ERTS CGM Warning Warning: Invalid Transmitter ID Invalid Transmitter ID/Serial Number entered in pump is not Transmitter Cause valid. Re-enter Effect Insulin deliveries continue. CGM does not start. Cancel Displayed until conﬁrmed or until pump goes into Message...
Page 159 Message conﬁrmed. Press to conﬁrm. Call Customer Support or your local Animas distributor for assistance. In the United Action 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).
Page 160 CHAPTER 1 0 - CG M SAF ET Y SY ST E M A ND AL ERTS CGM Warning Warning: CGM Sensor Error 0 CGM Sensor Error 0, Sensor error indicating that Sensor is not functioning Cause Insulin properly. Delivery Continues Insulin deliveries continue.
Page 161 Message conﬁrmed. Press to conﬁrm. Call Customer Support or your local Animas distributor for assistance. In the United Action 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).
Page 162 CHAPTER 1 0 - CG M SAF ET Y SY ST E M A ND AL ERTS CGM Warning Warning: Glucose Level Below 3.1 mmol/L Glucose Last CGM reading at or below 3.1 mmol/L (ﬁxed limit Level is Cause set in pump – not user selected). Below 3.1 mmol/L Effect...
Page 163 CHAP TER 1 0 - CG M SAF ETY SY STEM AN D AL ERTS CGM Alert Alert: CGM Session Active Transmitter ID/Serial Number number cannot be CGM Session Cause Active entered if CGM session is active. Effect Insulin deliveries continue. CGM continues. Message Displayed once for 4 seconds.
Page 164 CHAPTER 1 0 - CG M SAF ET Y SY ST E M A ND AL ERTS CGM Alert Alert: CGM Data Not Available While Pump Suspended Pump Suspended CGM menu options not available on pump while it is Cause suspended.
Page 165 Section III Care and Maintenance and Other Technical Information About Your Animas Vibe System ® ™...
Page 167 3 months. You can call Customer Support or your local Animas distributor (see page 187) to order an extra battery cap. O-ring...
Page 168 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.
Page 169 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.
Page 170 C H A P T E R 1 - C A R E A ND M AI N TE NA N C E...
Page 171 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. Wash your hands with mild soap and water. Slowly remove existing lens protection ﬁlm.
Page 172 C H A P TE R 2 - L E N S P ROTE C TI ON FIL M A P PL IC AT ION IN STR U CTIO N S Spray entire ﬁlm adhesive area and lens with solution. NOTE: Before proceeding, make sure the ﬁlm orientation matches the frame orientation of the lens.
Page 173 Reset clock to current time, being careful to check AM & PM. Disconnect from pump. Call Customer Support or your local Animas distributor. In the United Kingdom, call (free phone) Pump exposed to MRI 0800 055 6606. In Ireland, call 1 800 812 715. All other countries, call your local Animas distributor (see page 187).
Page 174 C H A P T E R 3 - TR OU B LE S HO OTI N G G UI DE LIN ES Troubleshooting hypoglycæmia: FOOD INTAKE POSSIBLE CAUSE OF LOW BG SUGGESTED SOLUTION Check bolus amounts and times. Bolus too large Bolus only enough to lower your BG to normal level.
Page 175 C H A P T E R 3 - TR OU B LE S HO OTI N G G UID EL IN ES Preventing hypoglycæmia: • Check BG a minimum of four times a day, and more frequently with exercise. •...
Page 176 C H A P T E R 3 - TR OU B LE S HO OTI N G G UI DE LIN ES Troubleshooting hyperglycæmia: INFUSION SET POSSIBLE CAUSE OF HIGH BG SUGGESTED SOLUTION Redness, irritation, inﬂammation, Change infusion set tubing and site. Contact health care swelling, discharge or discomfort team.
Page 177 C H A P T E R 3 - TR OU B LE S HO OTI N G G UID EL IN ES Troubleshooting hyperglycæmia: ACTIVITY POSSIBLE CAUSE OF HIGH BG SUGGESTED SOLUTION Less activity Use Temp Basal increase. Consult health care team. Record amount of time for changes.
Page 178 C H A P T E R 3 - TR OU B LE S HO OTI N G G UI DE LIN ES 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.
Page 179 C H A P T E R 3 - TR OU B LE S HO OTI N G G UID EL IN ES Problems with CGM Sensor Insertion Problems can occur during CGM Sensor insertion, and in keeping the Sensor Pod attached to your body.
Page 180 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.
Page 181 C H A P T E R 3 - TR OU B LE S HO OTI N G G UID EL IN ES 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, will appear instead of your current CGM reading on the CGM Data and Trend screens.
Page 182 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.
Page 183 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: •...
Page 184 C H A P T E R 4 - S I C K DA Y GU I DE LI N ES...
Page 185: Exercise And Sports
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).
Page 186 • 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.
Page 187 CHAP TE R 6 - MY INF ORMATION This chapter provides tables to record information needed for programming your personal settings into your pump. Consult your health care team 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...
Page 188 C HA P T E R 6 - MY I NF ORM ATI ON Temp Basal Rate Decrease for Activity Set Temp in advance Minutes to Activity Type % Decrease of activity (yes or no) set in advance Light (gardening, walking, shopping) Moderate (leisurely biking, golf {no cart}) Strenuous (basketball, jogging, swimming) Sustained (ice skating, rowing, hiking)
Page 189 C H A P T E R 6 - MY I N FORM A TI ON Basal Programming Date Program 1 Program 2 Program 3 Program 4 Segment Weekday Other Weekend Exercise Start Time Units/Hr Units/Hr Units/Hr Units/Hr Basal Programming Date Program 1 Program 2...
Page 190 C HA P T E R 6 - MY I NF ORM ATI ON Basal Programming Date Program 1 Program 2 Program 3 Program 4 Segment Weekday Other Weekend Exercise Start Time Units/Hr Units/Hr Units/Hr Units/Hr...
Page 191 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 ®...
Page 192 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.
Page 193 3048 meters (10,000 feet) Critical Audible Alarms: 50 dB(A) at 1m min., per IEC 60601-2-24. Pump Disposal: Contact Animas Corporation or your local Animas distributor (see page 187) for pump disposal information. Audio Bolus Range: 0.1–2.0U in 0.1U step 0.5–10.0U in 0.5U step...
Page 194: Performance Characteristics
C H A P TE R 7 - W A R RAN TY A ND OT HE R T E CH N ICA L IN F O R MA TIO N Performance Characteristics Flow Rate Accuracy Delivery Mode Accuracy Bolus +/- 5% Basal +/- 5%...
Page 195: Electromagnetic Emissions
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 ®...
Page 196 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.
Page 197 AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to ﬁxed RF transmitters, an electromagnetic site survey should be considered. If the measured ﬁeld strength in the location in which the Animas Vibe System ®...
Page 198 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 ®...
Page 199 C H A P T E R 7 - W A R RA N TY A N D OTHE R T E CH N IC AL IN F O R MA TIO N Pump ﬂow accuracy upon initial start up (per IEC 60601-2-24) Average ﬂow rate during a 30 minute period.
Page 200 C H A P TE R 7 - W A R RAN TY A ND OT HE R T E CH N ICA L IN F O R MA TIO N Technical Speciﬁcations – Dexcom CGM Sensor and Transmitter ® CGM Sensor Displayed Glucose Range 2.2–22.2 mmol/L (40–400 mg/dL)
Page 201 C H A P T E R 7 - W A R RA N TY A N D OTHE R T E CH N IC AL IN F O R MA TIO N CGM Transmitter Length: 3.8 centimeters (1.5 inches) Dimensions (including Width: 2.3 centimeters (0.9 inches) Sensor Pod)
Page 202 C H A P TE R 7 - W A R RAN TY A ND OT HE R T E CH N ICA L IN F O R MA TIO N Performance Characteristics PARAMETER PERFORMANCE CHARACTERISTICS Frequency Allocation ISM Band Transmitter Frequency Range 2.425 –...
Page 203 Appendix A: Glossary...
Page 205 12 hours obtain BG values from somewhere on your body thereafter. Calibrations are needed for your other than your ﬁngertip. Do Not use BG values Animas Vibe System to display continuous ® ™ from alternative site testing for CGM calibration.
Page 206 BG level in the morning Sensor. upon waking. Basal rate delivery by the Animas ® CGM transmitter - The CGM component that Vibe ™...
Page 207 APPE NDI X A : GLOSSARY glucose - Glucose is a carbohydrate and the insulin limits - Insulin limits are a body’s most important source of energy. It is programmable feature of the Animas ® Vibe ™ produced from digested food, by the normal Insulin Pump.
Page 208 18.02. subcutaneously. occlusion - Occlusion means “blockage.” The temporary (or temp) basal - Setting a temporary Animas Vibe Insulin Pump is designed to be ® ™ basal lets you increase or decrease your current able to sense when delivery of the insulin is basal program rate for a desired period of time.
Page 209 APPE NDI X A : GLOSSARY 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.
Page 210 APP ENDI X A: GLOS SARY...
Page 211 Index...
Page 213 INDEX Bolus insulin limits Bone densitometry Buttons Active basal program empty alert 27, 74 Advanced bolus 21, 48, 59 Advanced features AICD Calculator feature VII, 59 Air bubbles VIII, 152 Calibrating the CGM 63, 66, 105, 154 Aircraft VII, 160 Call service alarm, insulin delivery Alarms, CGM 114, 127...
Page 214 INDEX Contrast button/CGM shortcut 3, 4, 50, 110 Correction bolus see ezBG CT scans Help High altitude activities High (BG) alert, CGM 91, 110, 132 High BG alert, insulin pump Daily insulin limits High blood glucose (BG) IX, 114, 115, 149, 150, 151 Damage III, IV, VI, VIII, X, 2, 4, 9, 10, 14, History, CGM...
Page 215: Index
INDEX Radio Frequency (RF) X, XI, 87, 95, 155 Magnets III, VII Radiology equipment Main menu screen 6, 7 Rechargeable batteries, insulin pump VIII, 9 Maintenance, CGM Reminders 48, 59, 69 Maintenance, insulin pump Removing the CGM sensor/transmitter Mammogram Replace battery alarm, insulin pump Max basal insulin limits Replacement pump VIII, 160...
Page 216 INDEX Tamper resistant (Locked) feature TDD (total daily dose) insulin limits Technical and clinical help Technical speciﬁcations, CGM Technical speciﬁcations, insulin pump Temp basal 27, 28 Temp basal minimum rate alert Temperature VIII, 143 Temporary basal feature see Temp basal Therapeutic oncology Therapeutic radiation Time format...
Page 217: Animas Distributor Contact Information
ANIMAS DISTRIBUTOR CONTACT INFORMATION INDEX Austria Germany Spain Medtrust Animas EMEA ® NOVALAB IBÉRICA, S.A.L Handelsges.m.b.H Division of Cilag GmbH International c/ Argentina, 2 - P.A. E. Gewerbepark 10 Landis+Gyr-Strasse 1 Casarrubios 7221 Marz 6300 Zug Nave A-10 Austria Switzerland...
Page 220 Tel: +33 (0) 4 76 86 43 22 Fax: +33 (0) 4 76 17 19 82 Email: info@medimark-europe.com Compatible with ©2011 Animas Corporation. All rights reserved. This product is covered by one, or more, U.S. patents including 6,656,148. Other patents pending. Dexcom ® , Dexmitter ™...

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