Animas vibe User manual

Owner’s
booklet.
Get to know your system.
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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 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.
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TABLE OF CONTENTS
BEFORE YOU BEGIN I
SECTION I : 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 57
CHAPTER 11 - Pump safety system and alarms 73
SECTION II : DEXCOM®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
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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 III: 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
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I
BEFORE YOU BEGIN
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 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 I, 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:
• Test their blood glucose levels four to six times per day or as recommended by their health care
team.
• Demonstrate adequate carbohydrate counting skills.
• Maintain good diabetes self-care skills.
• 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
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II
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 programming and may not be representative of current health states.
• 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.
• “Blood Glucose” is often abbreviated as BG in both instructional copy as well as in example display
screens.
• “Continuous Glucose Monitoring” is often abbreviated as CGM in both instructional copy as well as
in example display screens.
• 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 .
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 older) 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 hyperglycæmia and hypoglycæmia,
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.
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III
BEFORE YOU BEGIN
 Warnings, Precautions and Important Safety Information about your
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.
Warnings, Precautions, Cautions, Contraindications and other important Safety information about
your Animas®Vibe™System follows below. Be sure to read the information carefully.
 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.
 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. If 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 hypoglycæmia.
• You must take a fingerstick test with your BG meter and use that BG value to make any insulin
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.
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IV
BEFORE YOU BEGIN
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 procedure)
CARDIAC
CATHETERIZATION
•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.
COLONOSCOPY •Pump, infusion set and CGM Transmitter/Sensor can remain on/in.
CT SCANS
•Do Not bring pump 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.
EKG •Pump, infusion set and CGM Transmitter/Sensor can remain on/in
ELECTRO-CAUTERY
•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.
LASER SURGERY •Pump, infusion set and CGM Transmitter/Sensor can remain on/in
MRI
•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.
NUCLEAR STRESS TEST
(myocardial perfusion
imaging)
•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.
 Guidelines Involving Use of the Animas
®
Vibe
™
System During Medical
Procedures
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V
BEFORE YOU BEGIN
Medical Procedure Device User (Patient or HCP administering the procedure)
PACEMAKER/AICD
Reprograming
•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.
THERAPEUTIC RADIATION/
ONCOLOGY
(cancer treatment
radiation)
•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.
ULTRASOUND •Pump, infusion set and CGM Transmitter/Sensor can remain on/in
X-RAY, BODY
FLUOROSCOPY
(chest, neck,
abdomen, torso, etc.)
•Do Not bring pump into the same room where the procedure is
being performed, unless a lead apron that completely covers
pump is worn during the procedure. The person administering
the procedure (if they are wearing a pump) must proceed to a
designated safety area during the procedure.
•Teflon/plastic infusion set can remain in. Other types of infusion
sets must be removed.
X-RAY, BONE
DENSITOMETRY
•Do Not bring pump or 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
procedure. The person administering the procedure (if they are
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 sets
must be removed.
X-RAY, DENTAL
•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.
X-RAY, MAMMOGRAM
•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.
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VI
BEFORE YOU BEGIN
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 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 Luer
connector. Efficacy of pump cannot be guaranteed if cartridges other than those manufactured by
Animas Corporation are used or if cartridges are used more than once.
•Always dispose of used cartridges and infusion sets following the regulations in your community.
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 I, 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 III,
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 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.
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VII
BEFORE YOU BEGIN
 PRECAUTIONS (continued)
•Yourpumpusesbatterypowertonotifyyouofalerts,warnings,andalarms.Ifyoudonotconrm
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.
•Consult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(I:C)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conrm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 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 III, 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.
 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.
41012850A_OB_Unity_OUS_EN_mmolL.indd 7 3/2/11 2:09 PM

VIII
BEFORE YOU BEGIN
 PRECAUTIONS (continued)
•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 check 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.
•Ifyoureturnyourpumpforserviceandareplacementpumpissent,DoNotusethe
replacement pump until all the settings specific to your treatment plan have been
programmed.
•Ifyoudrop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 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°F)
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.
41012850A_OB_Unity_OUS_EN_mmolL.indd 8 3/2/11 2:09 PM

IX
BEFORE YOU BEGIN
 WARNINGS:
•The CGM is not designed to replace a blood glucose meter. The CGM must be used with a
blood glucose meter.
•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
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.
 CONTRAINDICATIONS:
•The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.
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X
BEFORE YOU BEGIN
All mentions of screen displays, menus, buttons, etc. in Section II refer to the Animas®Vibe™Insulin
Pump unless specifically stated otherwise.
 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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.
•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ngerstick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.
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 the problem is resolved, RF communication will resume. Refer to page
155 for more information on conditions that may cause RF communication problems.
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XI
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.
41012850A_OB_Unity_OUS_EN_mmolL.indd 11 3/2/11 2:09 PM

XII
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
a
c
b
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XIII
BEFORE YOU BEGIN
Shown below are symbols you will find on your Animas®Vibe™Insulin Pump and its packaging.
On your pump kit packaging:
On the front of your pump:
Up Arrow button
Down Arrow button
OK button
On the top of your pump:
Contrast button/CGM shortcut
On the back of your pump:
Explanation of symbols
Do Not Reuse Pressure Limitations
Fragile Relative Humidity Limitations
Keep Dry Temperature Limitations
Caution (Consult Owner’s Booklet)
S/N Serial Number Shock Protection Type BF Medical
Equipment
Manufacturer Consult Owner’s Booklet
Date of Manufacture Do Not wear or operate around MRI
devices. Remove and leave outside
MRI room before entering.
IPX8
Protected against water submersion
– Pump tested to 3.6 meters (12 feet)
for 24 hours
Catalog Number
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XIV
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.
“Use by” Date
Caution (Consult Owner’s
Booklet)
Date of Manufacture
Do Not Reuse
Serial Number
Sterilized by Radiation
Do Not Use if Package
is Damaged
Lot Number
Catalog Number
Two-sided Temperature
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
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XV
BEFORE YOU BEGIN
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:
•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
•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.
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