BabyHeart HiFlow Wearable Breast Pump

Experience the future of breastfeeding with the BabyHeart HiFlow Wearable Breast Pump, designed for the modern mother. This hands-free, portable electric breast pump offers not only powerful suction but also a completely safe, comfortable, and efficient pumping experience.

Key Features:

• Enhanced Suction Power: Optimized for faster and more efficient milk expression, ensuring no valuable time is wasted.
• High Safety Standards: Made with food-grade silicone, guaranteeing a safe pumping journey for both mother and baby.
• Comfortable Fit: Comes with a soft, flexible flange and multiple size options (19mm, 22mm, 25mm) for a perfect seal and effective suction.
• Innovative Design: Features spill-proof technology with a one-way valve and enhanced flange, plus a convenient silicone plug for easy milk transfer.
• Ultra-Quiet Operation: Designed to operate discreetly, allowing you to pump peacefully while your baby sleeps.
• Wireless and Portable: Move freely and pump anywhere thanks to its lightweight, wire-free design.
• Intuitive Controls: Touch-sensitive screen for easy mode selection and adjustment, with 3 modes and 9 levels of suction.

Specifications:

• Material: Flange and milk container made from food-grade silicone and polypropylene
• Power: 5W, powered by a 1100mAh battery
• Charging Time: Approx. 2 hours
• Usage Time: Up to 120 mins
• Capacity: 150ml
• Dimensions: 1511.57cm
• Weight: 302g

What's Included:

• 1 X Breast Pump Motor
• 1 X Diaphragm
• 1 X Silicone Stopper
• 1 X Breast Shield (25mm)
• 1 X Dust-Proof Cover
• 2 X Silicone Inserts (19mm, 22mm)
• 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.