The Animas® Vibe™ System consists of the Animas® Vibe™ Insulin Pump paired with the Dexcom G4 PLATINUM Sensor and Transmitter. The Animas® Vibe™ Insulin Pump is indicated for continuous subcutaneous insulin infusion for the management of insulin-requiring diabetes. It can be used solely for continuous insulin delivery and as part of the Animas® Vibe™ System to receive and display continuous glucose measurements from the Dexcom G4 PLATINUM Sensor and Transmitter. The Animas® Vibe™ System’s continuous glucose monitoring (CGM) is indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes, and is intended to complement, not replace, information obtained from standard home glucose monitoring devices. CGM aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of results from the Dexcom G4 PLATINUM Sensor and Transmitter should be based on the trends and patterns seen with several sequential readings over time. The System is intended for single patient use and requires a prescription.
The Animas® Vibe™ System consists of the Animas® Vibe™ Insulin Pump and the Dexcom G4 PLATINUM Sensor and Transmitter. The pump is used to deliver insulin continuously throughout the day (basal insulin), and to deliver a single amount (bolus insulin) at meal times to cover carbohydrates (carbs) in the foods you eat. Bolus insulin is also used to lower a high blood glucose (BG). An insulin cartridge with about a 3-day supply of insulin is inserted into the pump. The pump connects to your body with a disposable infusion set that you replace every few days when you refill the pump with insulin. The Dexcom G4 PLATINUM Sensor and Transmitter automatically collect glucose readings every 5 minutes from fluid below your skin. The Sensor sits below your skin and is connected to the Transmitter. Readings are sent wirelessly to the pump display where you are alerted if your glucose readings are trending low or high, and can be used to help you make decisions for managing your diabetes. Every 7 days the disposable Sensor is replaced and a new one is connected to the same Transmitter. Transmitters are replaced about every 6 months. While using the Animas® Vibe™ System, you will continue to use a BG meter to obtain periodic glucose test results from a blood sample from your fingertips. Measurements from a BG meter are used to calibrate the Animas® Vibe™ System on a regular basis, and to help you make treatment decisions. It is necessary to calibrate the Animas® Vibe™ System to help ensure the accuracy of glucose readings from the Dexcom G4 PLATINUM Sensor and Transmitter. The Animas® Vibe™ Insulin Pump may be used with or without the Dexcom G4 PLATINUM sensor and Transmitter. If the Dexcom G4 PLATINUM Sensor and Transmitter are not used, you will not be able to automatically collect and receive glucose readings from fluid below your skin.
Your Animas® Vibe™ Insulin Pump provides an automated way to deliver basal and bolus insulin. The pump also provides an automated way to store personal diabetes and insulin health profile data that you can use to fine tune insulin delivery. This includes being able to store up to 12 Insulin Sensitivity Factors, 12 Insulin to Carb Ratios and 12 BG Targets, for different times of the day. Up to 4 basal programs can be stored in the pump to meet varying daily insulin needs. You can always use the TEMP Basal feature on your pump to temporarily adjust basal rates for a selected period of time.
Insulin pump therapy is not recommended for people with diabetes who are unwilling or unable to:
Not following these guidelines will make it hard for you to determine how much insulin you need based on your current health status and the foods you eat. Not seeing your HCP on a regular basis will not allow them to make adjustments to your pump settings and diabetes treatment plan that would be beneficial to your health. Not being able to respond to pump notifications means you may not be aware of certain health conditions or problems with your pump that require your attention.
As with any medical device, there are risks associated with using the Animas® Vibe™ System. While 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® Vibe™ System.
Your Animas® Vibe™ Insulin Pump is designed and calibrated to deliver U100 rapid-acting insulin. The following rapid-acting insulin has been tested by Animas® and found to be safe for use in the System: Humalog® and NovoLog®. The use of any other insulin with your System has not been tested.
NOTE: DO NOT exceed the insulin manufacturer’s recommended temperature and humidity ranges when operating the Animas® Vibe™ Insulin Pump.
Your Animas® Vibe™ System is designed to work safely and effectively in the presence of nearby wireless devices, and will not affect their performance. The Animas® Vibe™ System is designed to communicate only with the Dexcom G4 Transmitter via radio frequency. See Chapter 13 in Section II for complete information.
Your Animas® Vibe™ Insulin Pump has been designed to operate in the presence of common sources of electrostatic and electromagnetic interference, such as store security systems. However, your pump should not be exposed to very strong electromagnetic fields, such as Magnetic Resonance Imaging (MRI), RF welders, magnets used to lift automobiles, and some “free-fall” amusement park rides. Very strong magnetic fields, such as in an MRI, can damage the System.
Your system is designed to work safely and effectively when used within the operating guidelines covered in the Owner’s Booklet. These include the temperature, humidity, altitude and air pressure limitations noted in the Technical Specifications sections in Chapter 17 in Section I and Chapter 13 in Section II. Some environmental factors such as high gravity forces (e.g., when riding a roller coaster) or flying in aircraft without cabin pressurization can interfere with insulin delivery but will not damage the pump. Other environmental factors such as entering an area where there might be explosive gases can damage the pump. The Owner’s Booklet will provide information on those known environmental conditions and factors that can impact the safety and performance of the system. If you are unsure of whether a certain environmental condition or factor will impact the system or your health, contact your HCP or Customer Service.
Warnings are potential hazards that can damage the device, can cause over delivery and under delivery of insulin, or create other situations that can result in serious injury to your health, including death.
Examples of the type of activities during which disconnection is indicated include:
If you are unsure whether the activity is likely to interfere with your pump’s delivery of insulin, then disconnect temporarily during the activity.
This information is not intended to replace your healthcare provider’s recommendations, nor should it be used as a basis for diagnosis or therapy. Always follow the advice of your healthcare professional and the Instructions for Use that are provided with the product
Caution: U.S. law restricts this device to sale by or on the order of a licensed physician.
Animas insulin infusion pumps are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
The OneTouch® Ping® meter remote is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood, and as a wireless (RF) remote control to deliver insulin from the OneTouch Ping insulin pump. The meter-remote is intended for self-testing outside the body (for in vitro diagnostic use) by people with diabetes at home and Healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The meter remote is specifically indicated for use on the finger, arm or palm.
Insulin pump therapy is recommended for people with diabetes who are willing to:
This device generates, uses, and can radiate radio frequency energy and, if installed and used in accordance with the instruction, may cause harmful interference to radio communications.
Additional information: http://www.animas.com/support/onetouch-ping-insulin-pump