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The Electric Breast Pump (Models 918, HF918) is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Electric Breast Pump is intended for a single user.

The Electric Breast Pump (Model 918 and HF918) are powered breast pumps intended to express and collect milk from a lactating woman's breast. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The Electric Breast Pump is provided non-sterile and should be cleaned and disinfected according to the instructions for use prior to first use. The user employs buttons on the pump unit to select the pumping mode and vacuum level. The Electric Breast Pump has five basic modes: Stimulation mode, Expression mode, Two-in-one mode, Dual-Frequency mode, and Simulation mode has 5 suction levels (vacuum levels: 60-217.5 ± 20 mmHg; cycle speed: 39-123 ± 5 cycles/min), expression mode (vacuum levels: 105-285 ± 20 mmHg; cycle speed: 24-84 ± 5 cycles/min), dual-frequency mode (vacuum levels: 67.5-277.5 ± 20 mmHg; cycle speed: 39-85 ± 5 cycles/min), and two-in-one mode (vacuum levels: 75-285 ± 20 mmHg; cycle speed: 59-123 ± 5 cycles/min) have seven suction levels, and simulation mode (vacuum levels: 187.5 ± 20 mmHg; cycle speed: 14 ± 5 cycles/min) has one suction level. Stimulation mode is for massaging the breast to stimulate breast milk secretion. Expression mode is for pumping breast milk. Dual Frequency mode is for cycling between strong and weak pumping strengths. Two-in-One mode cycles between massaging for 5 cycles and expressing breast milk for 1 cycle. Simulation mode operates at a single suction level to stimulate milk secretion. The subject devices are available in two models: 918 and HF918. The hands-free (HF) model (HF918) is designed to be placed inside a user's bra and connect to the external pump unit. The milk collection cup is located on the breast. The HF model (HF918) includes breast shield assemblies, milk collection cups, single and double tubing sets, a bottle set, power adapter, and a pump unit. The non-HF model (918) includes a breast shield connected to a milk bottle. The non-HF model includes breast shield assemblies, bottles, bottle stands, single and double tubing sets, power adapter, and a pump unit. The Electric Breast Pumps are intended for a single user.