BabyHeart HiFlow Wearable Electric Breast Pump - FDA Cleared

Unlock the freedom of effortless breastfeeding with a wearable electric Breast Pump.  Experience unmatched suction strength, spill-proof design, and customizable comfort for efficient milk expression anytime, anywhere. Crafted with safety in mind, our pump is made from food-grade silicone, ensuring peace of mind for you and your baby. With fewer parts for easy cleaning and assembly, embrace the convenience and efficiency of modern motherhood. Upgrade your breastfeeding experience today with our Smart Union Electric Breast Pump, designed for the modern mom on the go.

Experience the Ultimate in Breast Pumping Convenience and Efficiency
Say goodbye to weak suction and hello to efficient milk expression with our breakthrough hands-free breast pump. Designed with moms in mind, our portable electric breast pump offers unbeatable suction strength (up to 282 mmHg), making it easier and faster to express milk.

Safety and Quality You Can Trust
Our breast pump is made with food-grade silicone, ensuring a safe and healthy experience for you and your baby. The soft, flexible flanges provide a comfortable and secure fit, while the 25mm flange (with additional 19mm and 22mm options) ensures a good seal for optimal suction.

Spill-proof, Anti-backflow and Mess-Free
Our wearable breast pump features a one-way duckbill valve and thickened flange to prevent spillage and back-flow, and our silicone plug makes pouring milk a breeze. Enjoy a mess-free experience that's both convenient and stress-free. 

Peaceful Pumping, Anytime, Anywhere
Our wireless breast pump is designed to provide robust suction while maintaining a peaceful environment, ensuring that you can pump powerfully while your baby sleeps soundly. With our lightweight and wire-free design, you can move freely and confidently, whether you're at work, on a trip, or even driving.

Customizable Comfort and Efficiency
Our chic, touch-sensitive glossy screen allows you to navigate effortlessly and customize your pumping session with 3 advanced modes, each with 9 levels of comfort and efficiency. Whether you prefer a gentle pull or a powerful pump, our breast pump adapts to your needs.

3 Modes & 9 Levels
Stimulation Mode, Expression Mode, Mixed Mode
Vacuum range (Stimulation Mode): 36 mmHg to 241 mmHg
Vacuum range (Expression Mode): 69 mmHg to 282 mmHg
Vacuum range (Mixed Mode): 68mmHg to 280mmHg
Cycle Speed (Stimulation Mode): 37.5 to 150 cycles/minute
Cycle Speed (Expression Mode): 23 to 72 cycles/minute
Cycle Speed (Mixed Mode): 12 to 21 cycles/minute

Easy Cleaning and Assembly
We know that mom life can be busy, which is why we've designed our wearable breast pump with fewer parts, making cleaning and setup a cinch.

Experience the Freedom of Hands-Free Pumping
Upgrade your breastfeeding experience with our Smart Union Electric breast pump, designed for the modern mom on the go. With our lightweight and wire-free design, you can enjoy the convenience of pumping anywhere, anytime.




Specifications:
Milk Container: Polypropylene
Flange: Silicone
Pump Outer Housing: Acrylonitrile Butadiene Styrene (ABS)
Voltage: DC 5V
Power: 5W
Battery Capacity: 1100mAh
Charging Time: around 2 hours
Working Time: about 120 mins
Milk Collector Capacity: 150ml
Dimension: 15*11.5*7cm
Weight: 302g

What's included: 
1 X Breast Pump Motor
1 X Diaphragm
1 X Silicone Stopper
1 X Breast Shield 25-27mm
1 X Dust-Proof Cover
1 X Silicone Insert 19-21mm
1 X Silicone Insert 22-24mm
1 X Milk Collector Cup
1 X USB Cable
1 X User Manual

❤️ Safety Tests We Have Done For Your Peace of Mind❤️ 

Biocompatibility testing
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA guidance Use of International Standard ISO 10993-1,
"Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
As dictated by the nature of body contact (intact skin) and contact duration (less than 24 hours), the following endpoints were evaluated for the patient-contacting components:
1) Cytotoxicity per ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
2) Sensitization per ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
3) Irritation per ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
The results of these tests demonstrated that the patient-contacting components of the subject device are noncytotoxic, nonsensitizing, and nonirritating.

Electrical safety and electromagnetic compatibility
The subject device has been tested in accordance with and found to comply with the following standards:
1) ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1:
General requirements for basic safety and essential performance
2) IEC 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
3) ANSI AAMI HA60601-1-11:2015 [Including AMD1:2021] Medical Electrical Equipment -- Part 1-11:
General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) [Including Amendment1 (2021)]
4) IEC 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications – Part 2: Lithium systems, and found to comply with all relevant sections.

Sterilization and Cleaning
The device is reusable, provided non-sterile, and is not sterile when used. The manual provides cleaning instructions.

Shelf-Life
Shelf life is not applicable due to the low likelihood of time-dependent product degradation. However, in accordance with IEC 60601-1:2005/(R)2012, the subject devices' expected use-life is 1500 pumping sessions of 30 minutes per session. In testing, the devices were demonstrated to operate within specifications for up to 1,500 pumping sessions, including at the maximum setting (Expression Mode, Level 9).

Performance Testing
1) Vacuum performance testing, cycle performance testing, and backflow protection testing were conducted at minimum and maximum vacuum settings to determine the pump's minimum and maximum vacuum levels compared to its specifications. The specifications were met for vacuum level, cycle rate, and backflow protection. These results were held under conditions of single pumping mode under battery power.

2) Use-life testing was conducted to demonstrate that the device maintains its performance specifications throughout its proposed use-life

3) Battery performance testing was conducted to demonstrate that the battery remains functional during its stated battery use life

4) Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life.