Safety Instructions

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 lling 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.