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Safety Information

Animas Safety Information

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.

Indications for Use:

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:

 

  • Test their blood glucose levels 4-6 times per day or as recommended by healthcare team;
  • Demonstrate adequate carbohydrate counting skills;
  • Maintain good diabetes self-care skills
  • See their health care professional regularly
  • And: Are able to adequately respond to pump alerts, warnings, and alarms.

Limitations:

  • The OneTouch Ping meter-remote should not be used for the diagnosis of diabetes or the testing of newborns

Warnings:

  • Animas insulin pumps use only rapid-acting insulin.  Any delay or interruption in insulin delivery may result in hyperglycemia (high blood glucose), which could lead to diabetic ketoacidosis (DKA).
  • Some studies have shown that intensive diabetes management has been associated with an increased incidence of hypoglycemia (low blood glucose). Because hypoglycemia can have serious consequences, work with your health care professional to determine proper blood glucose management
  • Only use rapid-acting insulin that has been prescribed by your physician, and do not modify your Animas insulin pump or accessories.

Precautions:

  • Establish a plan with your healthcare professional for quickly responding to any signs of hypoglycemia or hyperglycemia.
  • Prepare and carry an "emergency kit" of supplies such as insulin, self-monitoring blood glucose test strips and meter(s), urine ketone test strips, and insulin syringes or pen as a back-up plan.
  • If you are going to have diagnostic or surgical procedures that expose you to  X-ray, CT scan, MRI or any other type of radiation therapy, may need to remove your insulin pump (and meter-remote), and place them outside of the treatment area.    For specific procedure information please refer to the instructions for use that accompanied your insulin pump.  Consult your healthcare professional for direction in maintaining your blood glucose levels during these type of procedures.
  • Animas insulin cartridges are intended for single use only. Reuse of the cartridge can negatively impact product performance and can potentially contribute to infection, under-delivery of insulin, and insulin contamination.

FCC Notice

(OneTouch® Ping™ Glucose Management System only)

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

 

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