20
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:
•
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.
