1. Product Introduction
The Momcozy Wearable Breast Pump is intended to be used by lactating women to express and collect milk from their breasts. It forms a vacuum around the nipple to express breast milk, which is then collected in a milk collector.
The device features stimulation mode, expression mode, and mixed mode. Stimulation mode uses a quick, short sucking pattern to initiate milk flow. Expression mode employs a slow, deep sucking pattern for milk expression. Mixed mode combines a quick, short sucking pattern followed by a slow, long sucking pattern. A silicone diaphragm in the milk collection set physically separates the milk-contacting pathway from the vacuum system to prevent milk backflow.
This device is intended for a single user.
2. Warning Instruction and Precautions
The manual's warning signs and graphic symbols ensure safe and correct product use, preventing harm to users and others. Descriptions are as follows:
Symbol | Category | Description |
---|---|---|
⚠ | Warning | Alerts the reader about a situation that, if not avoided, could result in death or serious injury. May also describe potential serious adverse reactions and safety hazards. |
! | Precautions | Indicates a hazard alert warning of a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property. Also alerts against unsafe practices and highlights special care necessary for safe and effective use, or to avoid damage from use or misuse. |
Contraindications | Conditions under which the device should not be used because the risk of use clearly outweighs any possible benefit. May apply to persons with specific health statuses. | |
Notes | Indicates the need for attention; lack of attention may lead to incorrect use of the product or property device damage. |
Symbol Description
Symbol | Description |
---|---|
☂ | Keep Dry |
⎕ | Pile Limit 5 layers |
BF symbol | Applied part of type BF |
ⓘ | Refer to instruction manual. |
LOT | Batch code |
? | Manufacture date |
? | Manufacturer information: The manufacturer name and address |
SN | Serial Number |
☀ | Distribution packages shall not be exposed to sunlight |
? | For food contact |
IP22 | The first number 2: Protected against solid foreign objects of 12.5mm diameter and greater. The second number 2: Protected against vertically falling water drops when enclosure tilted up to 15°. |
♻ | Disposal in accordance with Directive 2012/19/EU (WEEE) |
MR symbol | This device has not been tested for use in an MR environment and should not be used exposed to MR environments while patients are wearing the device. Keep it outside the MRI scanner room. |
FC | FCC |
3. Indications for Use / Intended Use
Indications for Use / Intended use
The Momcozy Wearable Breast Pump (model: M5) is intended to express milk from lactating women to collect milk from their breasts. The device is intended for a single user.
Intended users
The intended user can read and understand the user manual. The PATIENT is an intended OPERATOR.
Patient Population
Lactating women
Intended use environment
Home Healthcare Environment
4. Contraindications
Do not use this Pump if you have an active implanted device that would be affected by a magnetic field (e.g., pacemaker; implantable cardioverter-defibrillator).
5. Safety Information
When using electrical products, especially if children are present, basic safety information should always be maintained.
5.1 ⚠ Warning
- Do not use this device if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electrical interference, or death.
- This breast pump is not intended for use by persons (including children) with reduced physical, sensory or mental capabilities, or lack of experience and knowledge. Such persons can only use this breast pump if they are supervised by or have received proper instruction concerning use of the appliance by a person responsible for their safety.
- Danger: To reduce the risk of electrocution:
- Always unplug electrical devices immediately after charging.
- Do not use while bathing, showering, driving or swimming.
- Do not reach for electrical product that has fallen into water; unplug the power adapter from wall outlet immediately.
- The Momcozy Wearable Breast Pump is a personal care item and for hygienic reasons should never be shared between mothers or resold from one mother to another. Either of these actions will void the warranty.
- If you are a mother who is infected with Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV), pumping breast milk using the Momcozy Wearable Breast Pump will not reduce or remove the risk of transmitting the virus to your baby through your breast milk.
- Close supervision is necessary when product is used near children or invalids. Do not allow children or pets to play with the motor unit, packaging materials or accessories.
5.2 ⚠ Precaution
- Do not place or store where product can fall or be pulled into bathtub, sink or pool.
- Do not place or drop product into water or other liquid.
- Do not immerse in any liquid for any reason or subject the unit to extreme shocks, such as dropping the pump.
- Do not continue pumping for more than five minutes at a time if you do not succeed in expressing any milk. Try to express at another time during the day.
- If discomfort is felt, then suction can be broken by inserting a finger between the breast and the flange.
- If irritation or discomfort occurs, discontinue use and see a health care provider.
- If the power adapter casing or wiring becomes loose, separated, or frayed, stop use of the power adapter immediately and contact the device manufacturer. Stop using the device immediately if you note any smoke or burning from the pump unit or power adapter.
Statement: If you feel excessive warmth from the Wearable breast pump while pumping, stop pumping immediately and remove pump.