Safety Instructions

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Reporting adverse events to FDA
MedWatch is the Food and Drug Administration’s (FDA) program for reporting serious reactions, product quality problems,
therapeutic inequivalence/failure, and product use errors with human medical products, including drugs, biologic products,
medical devices, dietary supplements, infant formula, and cosmetics.
If you think you or someone in your family has experienced a serious reaction to a medical product, you are encouraged to take
the reporting form to your doctor. Your health care provider can provide clinical information based on your medical record that
can help the FDA evaluate your report. However, we understand that for a variety of reasons, you may not wish to have the form
filled out by your healthcare provider, or your health care provider may choose not to complete the form. Your health care
provider is not required to report to the FDA. In these situations, you may complete the Online Reporting Form yourself.
You will receive an acknowledgement from the FDA when your report is received. Reports are reviewed by FDA staff. You will be
personally contacted only if we need additional information.
Submitting adverse event reports to FDA
Use one of the methods below to submit voluntary adverse event reports to the FDA:
1. Report Online at: www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
2. Consumer Reporting Form FDA 3500B. Follow the instructions on the form to either fax or mail it in for submission.
For help filling out the form, see MedWatchLearn. The form is available at:
www.fda.gov/downloads/aboutFDA/reportsmanualsforms/forms/ucm349464.pdf
3. Call FDA at 1-800-FDA-1088 to report by telephone.
4. Reporting Form FDA 3500 commonly used by health professionals. The form is available at
www.fda.gov/downloads/aboutFDA/reportmanualsforms/forms/ucm163919.pdf
Storage environment shall be expressed:
• The pump can be transported or stored for short periods of time within:
- Temperature range of -4 - 158°F (-20- 70°C)
- Humidity range of 10-93% RH non-condensing
- Atmospheric pressure range of 190 - 1060hPa
• Allow the pump to reach a reasonable room temperature of 50 - 86°F (10 - 30°C) before operating.
• When the system has been stored in extreme temperature conditions of -20°C (-4°F) or 70°C (158°F) between uses, wait
for two (2) hours before using again.