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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:
• 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 installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions,
may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
Radiation Exposure statement
This equipment complies with FCC/IC RSS-102 radiation exposure limits set forth for an uncontrolled environment.
