Safety Instructions
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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:
• 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.
FCC compliance statement
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device
may not cause harmful interference, and (2) this device must accept any interference received, including interference
that may cause undesired operation. Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of
the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential