Dexcom g4 platinum Quick Start Manual page 13

ANIMAS® VIBE™ SYSTEM
B EF O RE YO U BE G IN
Possible risks associated with using the Animas
As with any medical device, there are risks associated with using the Animas
some of the risks are the same as with multiple daily injections of insulin, there are additional risks
associated with continuous insulin delivery and continuous glucose monitoring. Review these risks
with your HCP before you begin using the Animas
• Not reading the Owner's Booklet or following the Instructions for Use poses a major risk for using the
Animas Vibe
®
system. Not following the proper procedures can lead to user error and result in serious injury to your
health, or damage to the system.
• Other risks associated with Animas
under delivery of insulin. Over delivery of insulin can result in very low BG levels (hypoglycemia).
Under delivery of insulin can result in very high BG levels (hyperglycemia). Over or under delivery of
insulin may be caused by problems with the pump or problems with the infusion set. It may also be
the result of the user not making the right decisions for how much insulin to take.
• Any damage to the system, or system malfunction, can result in over delivery or under delivery of
insulin. It can also leave you without your primary means of delivering insulin. Make sure to follow
the safety information throughout the Owner's Booklet, such as what to do with your system when
undergoing certain medical procedures.
• Risks associated with infusion sets include occlusions or air bubbles in the tubing which can affect
the delivery of insulin. Also, bruising and infection may occur at the infusion site.
• If you enable CGM on your Animas
making treatment decisions. CGM readings from interstitial fluid are different than BG values from a
BG meter and should not be used for making treatment decisions, such as how much insulin to take.
Relying on CGM readings to make treatment decisions may result in over delivery or under delivery of
insulin. There is also a risk of bruising or infection at the Sensor insertion site.
• Refer to the Warnings and Precautions in the Before You Begin section for information on risks
associated with infusion set and Sensor insertion sites. For risks associated with diabetic
ketoacidosis (DKA) such as nausea and vomiting, refer to the Diabetic Ketoacidosis (DKA) section in
Chapter 15 in Section I.
Insulin
Your Animas Vibe
®
following rapid-acting insulin has been tested by Animas
Humalog and NovoLog
®
NOTE: DO NOT exceed the insulin manufacturer's recommended temperature and humidity ranges
when operating the Animas
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System. It is important to follow the proper procedures for setting up and using your
™
Vibe
® ™
Vibe
® ™
Insulin Pump is designed and calibrated to deliver U100 rapid-acting insulin. The
™
. The use of any other insulin with your System has not been tested.
®
Vibe Insulin Pump.
® ™
Vibe
®
Vibe System.
® ™
System include the possible dangers of over delivery and
System, there is a risk of relying on CGM readings for
and found to be safe for use in the System:
®
V
Dec 2014
System
™
Vibe System. While
® ™
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