Evaluation of the Functionality of a Fluid Filled Single Breast Pump

C88- Pilot Study A Prospective Case Series for Evaluation of the Functionality of a Fluid Filled Single Breast Pump Applied on a Lactating Breast

This study is an early (during the product development process) feasibility study. It shall evaluate the device design concept with respect to device functionality of a new fluid filled breast pump in a small number of subjects.

Inclusion criteria:

• Female over 18 years
• Participant has an established milk flow, general rule: approx. 50 ml per breast per pumping session
• The participant is pumping at least 2 times a week
• The participant is 1-6 months after giving birth (postpartum) at the day of data assessment
• The participant agrees to pump or feed the last time a minimum of 3 hours before the start of the pumping sessions
• The participant agrees that the pumped breast milk cannot be fed to her infant (will be disposed)
• The participant agrees to photograph and video record the breast and upper body (no face)
• The participant agrees to the presence of up to 3 men in the room during the pumping session

Exclusion criteria:

• Participant or their baby is dependent on life-sustaining electric devices (e.g. heart pacemaker, insulin pump, etc.)
• Participant has an medical condition of the breast
• Participant is allergic to plastics or silicone