Momcozy Wearable Breast Pump V1 Pro

Model number: BP137

USER MANUAL

(For OTC Type of Use)

1. Product Introduction

The Momcozy Wearable Breast Pump is intended for use by lactating women to express and collect milk from their breasts. The Momcozy Wearable Breast Pump forms a vacuum around the nipple to express breast milk. The milk is collected in a milk collector. The device includes stimulation mode, expression mode, and mixed mode. In stimulation mode, the breast pump begins with a quick and short sucking pattern to get your milk to start flowing. In expression mode, the breast pump begins with a slow and long sucking pattern for milk expression, sucking more deeply and more slowly. In mixed mode, the breast pump begins with a quick and short sucking pattern, followed by a slow and long sucking pattern. To prevent milk from flowing into the vacuum system, the milk collection sets include a silicone diaphragm that physically separates the milk-contacting pathway from the vacuum system.

The device is intended for a single user.

2. Warning Instructions and Precautions

The warning signs and graphic symbols in the manual are intended to enable you to use the product safely and correctly and to prevent harm to you and others. Warning marks and graphic symbols are described as follows:

Warning/precautions symbols Description

Warning ⚠️

A warning alerts the reader about a situation that, if not avoided, could result in death or serious injury. It may also describe potential serious adverse reactions and safety hazards.

Precautions

Indicating a hazard alert that warns the reader 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. It may also be used to alert against unsafe practices. This includes the special care necessary for the safe and effective use of the device and the care necessary to avoid damage to a device that may occur as a result of use or misuse.

Contraindications

Contraindications are conditions under which the device should not be used because the risk of use clearly outweighs any possible benefit. There may be persons for whom the device should not be used because of their health status.

Notes ?

Indicates the need for attention, if not attention may lead to incorrect use of the product or property device damage.

Symbol Description

Keep Dry

Pile Limit 5 layers ?

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 titled up to 15°.

MR

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 logo

Disposal in accordance with Directive 2012/19/EU (WEEE) ♻️

3. Indications for Use

[Intended use]

The Momcozy Wearable Breast Pump (model: BP137) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

[Intended users]

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

No known Contraindications.

5. Safety Information

When using electrical products, especially if children are present, the following basic safety information should always be maintained.

5.1 Warning

  1. 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.
  2. 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.
  3. Danger: To reduce the risk of electrocution:
    • Always unplug electrical devices immediately after charging.
    • Do not use it while bathing, showering, driving or swimming.
    • Do not reach for electrical product that has fallen into water, please unplug the power adapter from wall outlet immediately.
  4. 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.
  5. 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.
  6. 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.
  7. Use product only for intended use as described in this manual.
  8. Do not use attachments or other milk collection components other than those recommended by manufacturer.
  9. Check the power adapter before charging, never use the damaged power adapter.
  10. Never leave product unattended while charging.
  11. Keep the product and all attachments away from heated surfaces.
  12. Never use it while sleeping or drowsy.
  13. Do not operate where aerosol spray products are being used or oxygen is being administered.
  14. Do not use the device around explosive or flammable material, in an MRI environment, in a hyperbaric chamber, or near a fireplace or radiant heater.
  15. Avoid strangulation resulting from Charging cable.
  16. Users are not allowed to repair the product. If you do so, your warranty becomes invalid. For repairs, sent to the manufacturer or a designated franchise distributor.
  17. Always switch off the breast pump before you remove the pump body from your breast, in order to release the vacuum.
  18. Powered breast pumps that are designed for single users should never be rented or shared.
  19. Never use the breast pump while you are pregnant, as pumping can induce labor.
  20. The high level temperature of applied part can reach max.43.9°C, excessive temperature may cause skin burns, please make sure that your skin of breast must be intact and healthy before use. If you feel overheated, please turn off the device. In order to avoid high temperature burn, the maximum continuous use shall not exceed 30min each time, the interval between two uses shall be at least 5min to allow the device to cool down.
  21. For product service life (i.e. working life) The device has no shelf life, and the service life of the product is 500 hours. The expected operating life of the washable parts is one to three months. Please check whether the product can run normally before use. Use beyond the service life may lead to the degradation of product performance. Such as, if the product cannot control the vacuum correctly, excessive vacuum may cause injuries.
  22. Keep the product away form children or pets, and avoid swallowing small parts.

5.2 Precaution

Statement: If you feel excessive warmth from the Wearable breast pump while pumping, stop pumping immediately and remove pump.

Notes: Avoid direct sunlight to the main unit.

6. Product Description

The product is mainly composed of main unit and milk collection set.

Fig. 1 unit description:

Diagram showing the components of the breast pump: 1. Double-sealed flange (24mm), 2. Tubing, 3. Valve, 4. Milk collector, 5. Main unit (Pump motor), 6. USB Type-C cable (Input end is USB 2.0 interface, the output end is Type-C interface).

NO. Item Description
1 Double-sealed flange (24mm) All of these components make up the milk collection set
2 Tubing
3 Valve
4 Milk collector
5 Main unit Pump motor
6 USB Type-C cable Input end is USB 2.0 interface, the output end is Type-C interface

Other Accessories Included:

Flange Insert, Valve, Flange Cover, Quick Start Guide, Flange Size Ruler, User Manual.

Fig.2 control panel

Diagram of the control panel with numbered buttons and indicators:

1. On/Off: Long-press to turn on/off the device;

2. Screen Lock

3. Running Time

4. Battery Display

5. Mode Indicator

6. Cycle Indicator

7. Mode Selection

8. Cycle Selection

9. Decrease

10. Increase

11. Timer

12. Pause / Continue

13. Suction Level Display

Buttons and LEDs

Icon Functions

On/Off ?

Long-press to turn on/off the device; Short-press to put the screen to sleep and press any button to activate the screen.

Pause/Continue ▶️

Pause/Continue your pumping session.

Mode Selection ↔️

Mode Selection

Decrease

Decrease suction level

Increase +

Increase suction level

Mode Descriptions

Icon Mode Description

❤️

Stimulation Mode In this mode, the breast pump begins with a quick and short sucking pattern to get your milk to start flowing.

?

Expression Mode The breast pump begins with a slow and long sucking pattern for milk expression, where the suction is deeper.

❤️?

Mixed Mode In this mode, the breast pump begins with a quick and short sucking pattern, followed by a slow and long sucking pattern.

88:88

Running Time Display

?

Screen Lock

〰️

Cycle Selection

Timer

7. Operating Instructions

7.1 Powering the Breast Pump

There are two power options available for your pumping session.

7.1.1 By the rechargeable built-in battery

Charge the pump for two hours before its first use. There are three indicator bars when the pump is fully charged.

7.1.2 By the charging cable

Plug the charging cable into the port on top of the pump motor.

7.2 Charging battery

Please charge the product before using it for the first time. The breast pump is powered by the internal rechargeable lithium battery.

Our product comes with a charging cable (USB2.0/Type-C line) but not with a power adapter. Please purchase the power adapter by yourself before charging. Make sure to buy the power adapter which matches the USB 2.0 interface, and please make sure the input power of the power adapter is AC 100-240V 50/60 Hz and the output power is DC 5V-2A.

Fig. 3 shows the charging interface.

Charge the battery as below:

  1. Insert the USB end of Charging cable into the USB interface of power adapter;
  2. Insert power adapter plug into AC socket;
  3. Insert the Type-C end of Charging cable into the charging port.

Fig. 4 shows the position of the charging port.

The device will take approximately 120 minutes to fully charge. When the pump is charged, the battery indicator bar increases one by one, from one bar to three bars, then switches off and repeats this process until the pump is fully charged. The display of three bars indicates that the battery is full.

Unplug the power adapter from the socket, disconnect the charging cable from the power adapter and main unit after charging is completed.

Warning ⚠️

Caution:

Using the wrong type of adapter or purchasing a poor-quality adapter may reduce the device's safety, and may damage your property and health. Please purchase the medical adapter that meets the IEC 60601-1 and IEC 60601-1-2 standards in professional medical markets, and make sure the output of the power adapter is DC 5V-2A.

Notes:

7.3 Cleaning and disinfection

7.3.1 General description/requirement

Providing breast milk is one of the best things you can do for your baby's health and development. Pumping your milk is one way to provide breast milk to your baby. Keeping the parts of your pump clean is critical because germs can grow quickly in breast milk or breast milk residue that remains on pump parts. Following these steps can help prevent contamination and protect your baby from infection. If your baby was born prematurely or has other health concerns, your baby's health care providers may have more recommendations for pumping breast milk safely.

1) BEFORE EVERY USE

2) AFTER EVERY USE

3) Parts that need to be cleaned and disinfected

Clean and disinfect all parts that come into contact with breast and breast milk before you use the breast pump for the first time and after every use. Cleaning and sanitizing are not the same. It's necessary to clean and disinfect the pump separately, so as to keep moms and babies safe and maintain the breast pump's performance.

Before cleaning / disinfection:

  1. Please Wash your hands well with soap and water for 20 seconds.
  2. Please disassemble all parts as follows:

    Fig. 5, Fig. 6, Fig. 7, Fig. 8 illustrate the disassembly steps.

    1. Separate the tubing from the pump.
    2. Separate the tubing from the milk collector.
    3. Detach the flange from the milk collector.
    4. Separate the valve from the milk collector.

Caution:

Never put the main unit, charging cable or the adapter (If you have purchased an adapter) in water or a dishwasher, as this causes permanent damage to these parts.

7.3.2 Cleaning and disinfecting parts contacting with the breast milk

Step 1: Cleaning

Please manually clean the device! The safety of using a dishwasher to clean and disinfect this product has not been verified.

Warning ⚠️

Do not use antibacterial or abrasive cleaning agents to clean the breast pump parts as this may cause damage.

1) Prepare the below items:

2) Rinse: Rinse parts of milk collection set and any other feeding items by holding them under running water to remove the remaining milk or dirt. The water can be warm or cold, whatever you prefer.

Fig. 9 shows rinsing the parts.

3) Wash milk collection parts:

Fig. 10 shows soaking the parts.

Fig. 11 shows air-drying the parts.

6) Clean wash basin and bottle brush: Rinse the wash basins and brush well and allow them to air-dry after each use. Wash them every few days by hand with soap and warm water. If your baby is less than 3 months old, was born prematurely, or has a weakened immune system due to illness (such as HIV) or medical treatment (such as chemotherapy for cancer), wash basin and bottle brush after every use.

After Cleaning:

For extra germ removal, disinfect the parts of milk collection set, wash basin, and bottle brush at least once daily after they have been cleaned. Items can be disinfected using boiling water with a disinfection setting. Disinfection is especially important if your baby is less than 3 months old, was born prematurely, or has a weak immune system due to illness or medical treatment.

For the disinfection of milk contact parts, please refer to step 2.

Step 2: Disinfection

Caution:

Before disinfection, make sure you have a cleaned milk collection set, bottle brushes, and wash basins using the methods above. Disinfect all items in contact with milk (even the bottle brush and wash basin!) by using one of the following methods.

1) Prepare the below items:

Caution:

During disinfection with boiling water, prevent the bottle or other parts from touching the sides of the pot. This can cause irreversible product deformation or damage.

2) Place the disassembled milk collection set in the pot and fill the pot with enough water to cover the components to disinfect. Let the water boil for 5-10 minutes, making sure the parts do not touch the sides of the pot.

Fig. 12 shows the boiling process.

3) Remove items with clean tongs.

Fig. 13 shows removing items with tongs.

4) Air-dry thoroughly.

Fig. 14 shows air-drying the parts.

Step 3: Store safely

Store dry items safely until needed. Ensure the clean pump parts, bottle brushes, and wash basins have air-dried thoroughly before storing. Items must be completely dry to help prevent germs and mold from growing. Store dry items in a clean, protected area to prevent contamination.

  1. Wash hands: Wash hands well with soap and water.
  2. Put back together: Put together the clean, dry pump parts.
  3. Store safely: Place reassembled pump parts and other feeding items, wash basin, and dry bottle brush in a clean, protected area such as inside a closed kitchen cabinet that is used only to store clean dishes.

7.3.3 Clean/Disinfect the other parts

The shell of the main unit need to be cleaned and disinfected for the first time and after each use. The other parts, do not come into contact with the human body nor the milk during pumping, and only need to be cleaned when it is dirty.

Cleaning/disinfecting the items at room temperature 5 °C~ 40 °C as below:

Prepare the below items:

Cleaning method:

  1. Before performing this cleaning procedure, wash your hands with hand disinfection first.
  2. Remove all residues from the main unit and/or charging cable using a clean soft cloth.
  3. Take a piece of 70% isopropyl alcohol wipes to swab on the parts until no visible contaminants remain.
  4. Dry the device by placing it at room temperature for 10min to evaporate the residual cleaning reagent solution on the product.

Disinfection method:

Cleaning the shell of the main unit as the above method before disinfection.

  1. Disinfect the shell of the main unit with a soft cloth dampened with the 70% isopropanol for 3 minutes.
  2. Dry it by placing the main unit at room temperature for 10min to evaporate the residual disinfection solution.

7.4 Direction for use

7.4.1 Preparation before use

Caution:

  1. Wash hands with soap and water, and inspect and assemble a clean pump kit.
  2. Duration of pumping session: This product is powered by a rechargeable lithium battery, after being fully charged, it can be used for 8-9 sessions (about 270 minutes) of pumping, 30 minutes per session. A typical pumping session lasts about 10-15 minutes per breast, but you should only pump as long as it is comfortable and productive for you.

1. Select Flange Size

This pump includes a 24mm silicone flange. If the flange provided does not fit, you can find flange or flange inserts of 21mm, 19mm, and 17mm available for purchase on Amazon / "momcozy.com”. Type "momcozy breast pump accessories" in the search bar and find the flange size and flange insert that fits you.

Fig. 15 select right size

Fig. 16 Flange size chart:

Nipple Measurement (mm) 11-13 13-15 15-17 17-20 20-23 23-26 26-29
Flange (mm) 15 17 19 21 24 27 30

2. Stimulate the Nipple

a) Stimulate your nipple to get a full size (do not skip this step!).

b) Place the nipple into the smallest hole you can comfortably fit into without forcing it.

c) Select the hole that can comfortably fit the very base of your nipple.

d) Get your measurement based on the sizing chart.

3. Test the Flange Fit

A. To find the suitable size flange, first, you need to make sure you place the flange in the right place on your breast.

B. Please press the flange on your breast until there is no gap. Make sure your nipple is right in the middle of the flange.

Fig. 17 and Fig. 18 illustrate flange fit.

Too Small

Too small: During pumping, if your nipple continues to rub against the inner wall of the flange, then this flange is too small for you.

Good Fit

Suitable fitting: During pumping, if your nipple moves smoothly without rubbing or touching the inner wall of the flange, and almost no areola is sucked inside, then this flange is right for you.

Too Large

Too large: During pumping, if a large area of areola is sucked inside, then this flange is too big for you.

4. GET THE RIGHT BRA

Fig. 19 illustrates bra features:

1. Made of stretchy fabric

2. No underwire or padding

3. Has a flap

4. Full coverage

Fig. 20 shows 'NO GAP' fit, where the silicone flange is pressed against the skin without a gap.

Fig. 21 shows 'IF IT MOVES' situation, suggesting to tighten bra straps or choose another bra.

5. RECOMMEND POSTURE

Caution:

Always sit or stand upright while pumping to prevent the milk from leaking. This pump is not to be used when lying down or sleeping to ensure the proper orientation is maintained during use.

POSTURE: Make sure the pump and the milk collector always stay at a vertical angle. Otherwise, the milk will spill out.

Fig. 22 shows the correct posture.

7.4.2 Assembling the Pump

Caution:

Make sure you have cleaned and disinfected the parts of the breast pump that come into contact with milk or breast.

Warning ⚠️

Notes:

Wash your hands thoroughly with soap and water, then assembling the pump as follows:

Fig. 23: Wash your hands thoroughly with soap and water.

Fig. 24: Gently push the valve into the milk collector. Make sure there are no gaps.

Fig. 25: First align the milk collector with the flange top, then press around to ensure a tight connection.

Fig. 26: Attach the diaphragm with the milk collector and secure the lid to form a tight seal.

Fig. 27 and Fig. 28 show Double Pumping and Single Pumping configurations.

5. Connect the long end of the tubing to the pump motor.

The breast pump is now ready for use.

7.4.3 Pumping instructions

Warning ⚠️

Caution:

  1. Monitoring milk level during pumping to ensure overfill does not occur.
  2. Pumping
    1. Assemble two milk collectors.
    2. Assemble the pump for double pumping.
    3. Put the pump in your bra.

3. Alignment

a. Before pumping, please make sure the pump is pressed tightly on your breast without a gap.

Fig. 29 shows proper placement.

b. To align, hold the flange against your breast so you can see if your nipple is centered in the flange tunnel. You may need to bend forward.

c. After you've aligned, look through the flange to confirm your nipple is centered before pumping. The tip of your nipple should NOT touch the top, sides or bottom of the flange tunnel. If it does, try again.

Fig. 30 shows Correct Alignment and Incorrect Alignment.

Notes:

4. Secure pump in bra

Secure Pump in place by bra, taking care to keep Pump pressed firmly against breast. If necessary, tighten bra to keep pump securely in place and start pumping.

5. Starting pumping

Fig. 31 illustrates starting the pumping process.

Do not slide the pump directly into your bra, follow the step-by-step instructions. Disconnect from charger before use.

A. Turn on the pump

Long press the On/Off button ? to turn on the pump.

B. Select the mode

Modes: Stimulation Mode ❤️, Expression Mode ?, & Mixed Mode ❤️?

Short press the Mode Selection button ↔️ to change from 3 modes.

C. Select the vacuum level

Momcozy pump has 15 vacuum pressure settings for each mode, giving you control over what feels comfortable and works most efficiently in all modes.

Once you feel uncomfortable, use the Increase + / Decrease – buttons to adjust the vacuum.

D. Screen Lock

After starting the breast pump, if there is no operation for 30 seconds, the lock screen ? will begin to flash and remain steady after 3 seconds. The keypad lights will also turn off to ensure that you won't disrupt your breast pumping settings due to accidental key presses. Simply press the power button briefly to unlock.

After the screen is locked, and there is no operation for 10 seconds, both the screen and keypad lights will automatically turn off. Touching any key will illuminate the screen, and a brief press of the power button ? will unlock it.

E. Pressure

Always ensure you are pumping at a comfortable level.

F. Cycle Selection

Under each suction level, there are three cycle options to choose from:

The breast pump defaults to a medium cycle under each suction level upon startup; you can change the cycle by using the cycle adjustment button 〰️ to find a comfortable breast pumping rhythm. When you switch to another mode, the breast pump will remember the current level and cycle under that mode.

Every woman is different, so adjust the cycle speed setting to find the speed that works best for you.

G. Setting the Breast Pump Timer

The default timer on the breast pump will start counting down from 30 minutes. If you want to set a different time, follow the steps below:

Before starting breast pumping, press the timer button ⏰. The time indicator 88:88 will start flashing. Use the "+" and "-" keys + - to set the pumping time in five-minute increments. You can set a timer for a maximum of 40 minutes and a minimum of 5 minutes.

Tip: A higher vacuum pressure does not always mean a higher volume of milk. Putting your nipple under excess stress can reduce milk production. Always ensure you are pumping at a comfortable level. If you don't feel suction, please check the pump is assembled correctly.

Caution:

6. Pause / Continue Pumping

Press the Pause / Continue button ▶️ to stop pumping and you will see the pumping time in the LED screen.

Press the Pause / Continue button ▶️ again to continue your pumping session.

7. Turn off the pump

Long press the On / Off button ? to turn off the pump.

8. Remove the pump

Use your finger to break the seal between the flange and the breast tissue. Lean slightly forward to remove the pump from the breast after your pumping session, then keep the flange opening side up to prevent milk from pouring over.

Fig. 32 shows removing the pump.

7.5 Storing breast milk

7.5.1 Proper storage of breast milk

Following the recommended storage and preparation techniques can maintain the safety and quality of expressed breast milk for the baby's health.

These are general guidelines for storing human milk at different temperatures. Various factors affect how long human milk can be stored safely. Such factors include milk volume, room temperature when milk is expressed, temperature fluctuations in the refrigerator and freezer, and cleanliness of the environment.

Storing breast milk after expressing:

Type of Breast Milk Countertop (room temperature) Refrigerator (40 °F (4°C)) Freezer (0°F (-18 °C) or Colder)
Freshly Expressed or Pumped Up to 4 Hours Up to 4 Days Within 6 months is best
Up to 12 months is acceptable
Thawed, Previously Frozen 1-2 Hours Up to 1 Day (24 hours) NEVER refreeze human milk after it has been thawed
Leftover from a Feeding (baby did not finish the bottle) Use within 2 hours after the baby is finished feeding

These guidelines are for healthy full-term babies only and may vary for premature or sick babies. Check with your health care provider.

Storage tips:

7.5.2 Safe thawing of breast milk

8. Transfer

When traveling, please use the charging cable provided and adjust it to the right power source for your current location. Before boarding the plane, please consult the airline for advice about carrying or using this pump on the plane.

Temperature: -20 to 60 °C/-4 to 140 °F

Relative Humidity: 15% – 90%

Ambient Pressure: 70 - 106kPa

9. Storage Condition

How to store the pump

Short-term storage

Long-term storage

First, please charge the pump before long-term storage in which way the service life of this pump can be prolonged. Second, keep it in a place away from direct sunlight in avoidance of discoloration. Third, clean and dry the washable parts before storing them.

10. Specification

Model BP137
Name Wearable Breast Pump
Power requirements Input: 100-240Vac, 50/60Hz;
Output: 5V-2A (Charge through provided USB 2.0/Type-C Charging cable and self-purchased power adapter)
Power supply DC 3.7 V / 2300mAh Rechargeable lithium battery
Rated power 10W
Suction modes Stimulation mode, expression mode, and mixed mode
Vacuum range Stimulation mode: -55~-175mmHg
Expression mode:-100~-300 mmHg
Mixed mode: -55~-300 mmHg
Cycle speed Stimulation mode: 48-98 cycle/min
Expression mode: 20-67 cycle/min
Mixed mode: 40-83 cycle/min
Dimensions 97.09mm X 104.12mm X 50mm (pump motor)
123mm X 111mm X 72mm (milk collector)
Weight 240g (pump motor weight)
130g (single milk collector weight)
Product use life 500 hours
Noise level ≤48dBA
Type of protection against electric shock Internally powered equipment
Degree of protection against electric shock Type BF applied part (milk collection set)
Operating conditions Temperature: 0°C to 40°C; Humidity: 15% to 90%, Atmospheric pressure: 70 kPa to 106 kPa
Transportation & storage environment Temperature: -20 °C to 60 °C; Humidity: 15% to 90%, Atmospheric pressure: 70 kPa to 106 kPa
Battery charging time 120 minutes
Battery usage time 270 minutes

11. Maintenance and Replacement Parts

The device contains no user serviceable parts inside: Opening or tampering with this device will void the warranty. In the event the device requires repair, it should be returned to the medical equipment company or to retailer directly. Modification of any kind is prohibited.

The MANUFACTURER will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other information that will assist SERVICE PERSONNEL to repair those parts of the device that are designated by the MANUFACTURER as repairable by the SERVICE PERSONNEL. When the product is not used for a long time, the battery will discharge slowly. In order to avoid battery damage due to low voltage for a long time, please charge the device every three months.

Warning ⚠️

The replacement of lithium batteries by inadequately trained personnel could result in a hazard.

Do not clean or maintain the device while the device is in use or while charging.

12. Declaration of Conformity

Shenzhen Root Innovation Technology Co., Ltd. declares that the device conforms to the following standards IEC60601-1, IEC60601-1-2, IEC60601-1-11, IEC62304, ISO10993-5, ISO10993–10, ISO10993-23, ISO10993-1, ISO 14971.

13. Troubleshooting

Problems Solutions
Pump does not work
  • If let-down has not yet occurred, consider leaving the pump on breast for longer period of time to observe for possible delayed let-down. Note: Initial milk let-down time is unique for each person and varies by many factors.
  • Check nipple alignment, pause the pump, and remove it from breast. Realign the pump as described below.
  • You may not have the correct Flange size.
Milk does not flow
  • Pause the pump and remove it from breast. Realign it correctly.
  • You may also separate the pump from the flange to realign . Then, center your nipple in the flange tunnel and bring the pump to your breast.
Need to realign
  • Pause the pump and remove it from breast. Realign it correctly.
  • You may also separate the pump from the flange to realign.Then, center your nipple in the flange tunnel and bring the pump to your breast.
Feel discomfort while pumping
  • If you're experiencing excessive discomfort, please try the following:
    • Make sure to press the pump firmly against your breast during Stimulation on mode.
    • Tighten bra to make sure the pump is held firmly against the breast.
    • Decrease suction level.
    • Realign the pump.
    • You may be pumping for too long. This pump shuts off automatically after running for 30 minutes.
    • You may not have the correct flange size. Stop and see a medical professional or breastfeeding specialist.
Decreased (low) pump suction
  • The Pump has 15 suction settings. Press the increase button to increase suction level.
  • Check the condition of your washable parts. They should be replaced after three months of use.
  • If that does not work, try the following:
    1. Check connections between all washable parts to ensure all are secure.
    2. Visually inspect all washable parts and replace them if damaged.
    3. Check that power is on.
    4. Press the Pump securely against the breast.
Stop pumping
  • This pump shuts off automatically after running for 30 minutes.
  • Short press Pause/Continue button will pause the pump, press again will resume.
Pump does not stop pumping
  • Press the Pause/Continue button.
  • If the issue persists, then break the seal by inserting a finger between the breast tissue and the flange. Then press the On/Off button to turn the pump off.
Pump or Charger gets wet (immersed in water).
  • Dry the pump immediately. Prop the pump upright with charger port down and suction controls up, and let it air dry overnight. Do not use the pump or charger within 24 hours.
  • Contact Customer Care.
Pump is not charging.
  • Ensure the USB Type-C cable with standard charger (not included) is fully plugged into the pump charging port.

Remark: If the above methods still do not solve the problem, please contact the manufacturer, see the last page for contact information.

14. Disposal

At the end of the product life cycle, do not throw this product into the normal household garbage, but bring it to a collection point for the recycling of electronic equipment and battery. Waste Electrical and Electronic Equipment may have potentially harmful effects on the environment. Improper disposal may lead to the accumulation of harmful toxins in the air, water, and soil, which is harmful to human health. you have obligation to dispose of the device correctly. Consult your municipal authority for information about disposal.

15. Warranty

Please contact the manufacturer in case of a claim under the warranty, the contact information please refer to last page of this user manual. If you have to send the unit, enclose a copy of your receipt with clear statement of defect description.

The warranty terms are as below:

  1. In case of a warranty claim, the date of purchase has to be proven by means of the sales receipt or invoice.
  2. Repairs under warranty do not extend the warranty period either for the device or for the replacement parts.
  3. The following cases are excluded under the warranty
    • All damages which are arisen due to improper treatment, e.g. nonobservance of the user instruction.
    • All damages which are arisen due to repairs or tampering by the customer or unauthorized third parties.
    • Damages which are arisen during transport from the manufacturer to the consumer or during transport to the service center.
    • Accessories which are subject to normal wear and tear.
    • Device damage due to privately disassemble devices.

Liability for direct or indirect consequential losses caused by the unit is excluded even if the damage to the unit is accepted as a warranty claim.

16. EMC Information

The equipment with following ESSENTIAL PERFORMANCE is intended used in Home healthcare environment facility environment.

Essential Performance:

Device- Specific Function Device-Specific Pass/Fail Criteria Detection/ Testing Method
Vacuum strength (mmHg) Stimulation mode: -55~-175mmHg
Expression mode:-100~-300 mmHg
Mixed mode: -55~-300 mmHg
Vacuum manometer
Observation
Cycle speed (cycles / min) Stimulation mode: 48-98 cycle/min
Expression mode: 20-67 cycle/min
Mixed mode: 40-83 cycle/min
Observation
Maximum vacuum ≤-300mmHg Vacuum manometer
Observation
Software for suction pressure regulation ≤-300mmHg Vacuum manometer
Observation
Backflow prevention mechanism No leakage at maximum vacuum Observation

If Essential Performance is lost or degraded due to electromagnetic disturbances, this may result in loss of product function or injury to patients, please read below important information before to avoid possible electromagnetic disturbances

Warning ⚠️

Caution:

  1. Security, antitheft, and radiofrequency identification (RFID) devices. Some electromagnetic anti- theft systems and metal detectors such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect the Momcozy Wearable Breast Pump. Please do not use Momcozy Wearable Breast Pump near these places. Additionally, RFID devices, which are often used to read identification badges, as well as some tag deactivation devices, such as those used at payment counters at stores and loan desks at libraries, may also affect the Momcozy Wearable Breast Pump. Please do not use Momcozy Wearable Breast Pump near these places. If you have to go through one of these devices, turn off your Momcozy Wearable Breast Pump. Before each usage, checking the status of your Momcozy Wearable Breast Pump to ensure it can operate normally.
  2. Using short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) and electrocautery devices near this product may cause malfunction or lead to loss of performance, please do not use Momcozy Wearable Breast Pump near this equipment.

A list of cables and maximum length of cables is as follows:

Cables name Cable length Whether shielding
Charging cable 1000±10mm No

Guidance and manufacture's declaration – electromagnetic emission

The Momcozy Wearable Breast Pump is intended for use in the electromagnetic environment specified below. The customer of the user of the Momcozy Wearable Breast Pump should assure that it is used in such an environment.

Emission test Compliance Electromagnetic environment – guidance
Conducted and Radiated RF emissions CISPR 11 Group 1 Class B The Momcozy Wearable Breast Pump uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any inter
Conducted and Radiated RF emissions CISPR 11 Group 1 Class B The Momcozy Wearable Breast Pump is suitable for use in all establishments, including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes except for near active HF surgical equipment and the RF shielded room for magnetic resonance imaging.
Harmonic emissions IEC 61000-3-2 Class A
Voltage fluctuations/flicker emissions IEC 61000-3-3 Complies

Guidance and Manufacturer's Declaration – Electromagnetic Immunity

The Momcozy Wearable Breast Pump is intended for use in the electromagnetic environment specified below. The customer or the user of the Momcozy Wearable Breast Pump should assure that it is used in such an environment.

Immunity Test IEC 60601-1-2 test level Compliance level Electromagnetic environment– guidance
Electrostatic discharge IEC 61000-4-2 ±8 kV contact
±2 kV, ±4kV, ±8 kV, ±15 kV air
±8 kV contact
±2 kV, ±4kV, ±8 kV, ±15 kV air
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Radiated RF EM fields IEC 61000-4-3 10V/m (Home healthcare environment), 80MHz-2.7GHz 80% AM at 1kHz 10V/m (Home healthcare environment), 80MHz-2.7GHz 80% AM at 1kHz
Electrical fast transients/bursts IEC 61000-4-4 ±2kV AC power supply lines; ±1kV DC power/Signal lines. 100 kHz repetition frequency ±2kV AC lines; power quality should be that of a HOME HEALTHCARE ENVIRONMENT.
Surges IEC 61000-4-5 ±0.5kV, ±1kV lines to lines; ±0.5kV, ±1kV, ±2kV lines to earth ±0.5kV, ±1kV lines to lines; power quality should be that of a HOME HEALTHCARE ENVIRONMENT.
Conducted disturbances induced by RF fields IEC 61000-4-6 3V 0.15MHz - 80MHz, 6V in ISM bands between 0.15MHz and 80MHz 80% AM at 1kHz 3V0.15MHz - 80MHz, 6V in ISM bands between 0.15MHz and 80MHz 80% AM at 1kHz power quality should be that of a HOME HEALTHCARE ENVIRONMENT.
Rated power frequency magnetic fields IEC 61000-4-8 30A/m 50Hz or 60Hz 30A/m 50Hz or 60Hz Power frequency magnetic fields should be at levels characteristic of a HOME HEALTHCARE ENVIRONMENT.
Voltage dips IEC 61000-4-11 0% UT, 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270°and 315°; 0% UT, 1 cycle and 70% UT, 25/30 cycle Single phase: at 0° Applicable power quality should be that of a HOME HEALTHCARE ENVIRONMENT.
Voltage interruptions IEC 61000-4-11 0% UT, 250/300 cycle Applicable

Note: The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.

NOTE: UT is the a.c. mains voltage prior to application of the test level. E.g.: 25/30 means 25 periods at 50 Hz or 30 periods at 60 Hz.

Guidance and manufacture's declaration – electromagnetic immunity

The Momcozy Wearable Breast Pump is intended for use in the electromagnetic environment specified below. The customer or the user of the Momcozy Wearable Breast Pump should assure that it is used in such an environment.

Immunity test IEC 60601-1-2 test level Compliance level Electromagnetic environment – guidance
Proximity fields from RF wireless communications equipment IEC 61000-4-3 See the following table Complies
Proximity magnetic fields IEC 61000-4-39 See the following table Complies

Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment

Test frequency (MHz) Banda) (MHz) Service a) Modulation Immunity Test Level (V/m)
385 380-390 TETRA 400 Pulse modulation b) 18 Hz 27
450 430-470 GMRS 460, FRS 460 FM ± 5 kHz deviation 1 kHz sine 28
710 Pulse modulation b) 217 Hz
745 704-787 LTE Band 13, 17 Pulse modulation b) 217 Hz 9
780
810
870 800-960 GSM 800/900, TETRA 800, IDEN 820, CDMA 850, LTE Band 5 Pulse modulation b) 18 Hz 28
930
1720
1845 1700-1990 GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS Pulse modulation b) 217 Hz 28
1970
2450 2400-2570 Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 Pulse modulation b) 217 Hz 28
5240 WLAN 802.11 a/n Pulse modulation b) 217 Hz
5500 5100-5800 9
5785

NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.

a) For some services, only the uplink frequencies are included.

b) The carrier shall be modulated using a 50% duty cycle square wave signal.

c) As an alternative to FM modulation, the carrier may be pulse modulated using a 50% duty cycle squire wave signal at 18 Hz, While it does not represent actual modulation, it would be worst case.

Test specifications for enclosure port immunity to proximity magnetic files

Test frequency Modulation Immunity test level (A/M)
30 kHz a) CW 8
134.2 kHz Pulse modulation b) 2.1 kHz 65 a)
13.56 MHz Pulse modulation b) 50 kHz 7.5 a)

a) This test is applicable only to ME EQUIPMENT and ME SYSTEMS intended for use in the home healthcare environment.

b) The carrier shall be modulated using a 50% duty cycle square wave signal.

c) r.m.s, before modulation is applied

17. Reporting Adverse Events

MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, including drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics.

If you think you or someone in your family has experienced a serious reaction to a medical product, you are encouraged to take the reporting form to your doctor. Your health care provider can provide clinical information based on your medical record that can help FDA evaluate your report.

However, we understand that for a variety of reasons, you may not wish to have the form filled out by your health care provider, or your health care provider may choose not to complete the form. Your health care provider is NOT required to report to the FDA. In these situations, you may complete the Online Reporting Form yourself.

You will receive an acknowledgement from FDA when your report is received. Reports are reviewed by FDA staff. You will be personally contacted only if we need additional information.

Submitting Adverse Event Reports to FDA

Use one of the methods below to submit voluntary adverse event reports to the FDA:

  1. Report Online at: www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
  2. Consumer Reporting Form FDA 3500B. Follow the instructions on the form to either fax or mail it in for submission. For help filling out the form, see MedWatchLearn. The form is available at: www.fda.gov/downloads/aboutFDA/reportsmanualsforms/forms/ucm349464.pdf
  3. Call FDA at 1-800-FDA-1088 to report by telephone a) Reporting Form FDA 3500 commonly used by health professionals. The form is available at: www.fda.gov/downloads/aboutFDA/reportmanualsforms/forms/ucm163919.pdf

18. Travel or International Use Statement

Since the performance of the Momcozy Wearable Breast Pump may be affected by the external environment, in view of the uncertainty and instability of the travel environment, please do not use the device during travel or on the aircraft.

The Momcozy Wearable Breast Pump can be internationally used, but it must be used and stored in the environment specified in this user manual, and please make sure the input power of your power adapter is AC 100-240V 50/60 Hz and output power is DC 5V=2A, and please make sure you have a converter to convert to the proper voltage of the target country. To ensure that the Momcozy Wearable Breast Pump is not affected during carrying, please check the following items before use to ensure it can operate normally:

If there is any abnormality, please stop using it.

19. Manufacturer Information

Shenzhen Root Innovation Technology Co.,Ltd.

#2-201, Floor 2, Hasee Computer Building, No.2 Beier Rd, Bantian Street, Longgang, Shenzhen, Guangdong, China, 518129

E-mail: support@momcozy.com

If assistance in setting up, using, or maintaining the device when needed or to report unexpected operation or events, please contact us.

20. FCC Compliance Statement

Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.

This device complies with part 15 of the FCC Rules.Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

IMPORTANT NOTE:

Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates,uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation.If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Models: V1pro, BP137 V1 Pro Wearable Breast Pump, BP137, V1 Pro Wearable Breast Pump, Wearable Breast Pump, Breast Pump, Pump

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