ELVIE PUMP EP01 (02) PDF DOCUMENT

Intended Use:

The ELVIE PUMP EP01 is a powered breast pump designed to express and collect milk from lactating women. The device is intended for a single user.

Operating Life:

• The operating life of the Hub is defined to be approximately 500 hours.

• The expected operating life of the replaceable washable components is six months.

• It is recommended to replace the washable components after long-term storage or before pumping for your next child.

1. Press the Bottle Release to separate the Bottle from the Hub.

2. Remove the Valve from the Spout.

3. Twist the Spout to remove it from the Bottle.

4. Pull the Breast Shield away from the Hub to remove it.

5. Take the Seal off the Breast Shield.

After disassembly, you can use the Spout to pour your expressed milk into a container of your choice for storage or feeding.

The ELVIE PUMP EP01 is not provided sterile and must be cleaned and sterilized before first use. Always take apart the components before cleaning or sterilizing.

The Hub (Electronics Care):

The Hub contains electronics that should be kept dry. A clean, damp cloth can be used to clean the Hub. The black semicircle on the base of the Hub monitors milk volume; please keep this area dry and clear of residue. Any other cleaning method will be classed as misuse.

Washable Components (Breast Shield, Seal, Lid, Valve, Spout, Bottle):

Cleaning washable components that come into contact with milk prevents the build-up of dry milk residue, which can cause the growth of harmful bacteria.

To Clean Washable Components:

1. Rinse in cold, clear water (approx +20°C / +68°F).

2. Wash in warm water (approx +30°C / +86°F) using mild dish washing soap and wipe afterwards with a clean cloth.

3. Rinse with cold, clear water (approx +20°C / +68°F) for 10 to 15 seconds.

OR

Place on the top shelf of the dishwasher.

To Sterilize Washable Components:

Boil in water for five minutes.

OR

Use microwave, steam or cold water sterilizing methods. It is not recommended to use microwave or steam sterilizing for more than five minutes. Some steam and microwave sterilizers reach high temperatures which may risk warping plastic parts. Ultraviolet sterilization is not recommended.

Always dry components completely before assembly.

The ELVIE PUMP EP01 must be fully charged before first use and will not operate out of the box.

1. When charging, the Battery Light will be orange and the pump will not turn on.

2. When fully charged, the Battery Light will be green.

3. When the battery is low, the Battery Light will be red.

The ELVIE PUMP EP01 comes with Breast Shields in two sizes (24mm and 28mm included, 21mm available separately) to help you find a comfortable fit.

1. To determine the correct size, put the Breast Shield on with the sizing symbol facing upwards and place your nipple in the center of the fit lines. The fit lines should align with the outside of your nipple.

2. Try different Breast Shields to find the best fit for you. A correct fit should not be too small or too big.

3. To comfortably pump on both sides, repeat this process for both nipples to ensure you have the correct Breast Shield for each nipple.

To align the Breast Shield when putting it on:

• Bend forwards and hold your breast from underneath.

• Bring the Breast Shield to your breast, paying attention to the direction of your nipple.

• You can use the markings on the Breast Shield to help align your nipple.

1. Make sure all parts are dry before putting them together.

2. Push the Breast Shield into the Hub.

3. Twist and click the Spout onto the Bottle.

4. Push the Valve onto the Spout.

5. Click the Bottle onto the Hub until it is secure.

Turning on: Once fully assembled, press the Power button to switch the ELVIE PUMP EP01 on. The Play/Pause button will flash.

Finding the right compression: The pump is designed to be worn with a standard nursing bra. It needs to be firmly pressed against your breast with no gaps. If you are using a particularly structured and inflexible bra, the included Bra Adjuster may be used to create more room. The Elvie logo on the Bra Adjuster should face outwards. Bra Adjusters are machine washable.

Starting a session: Once the pump is turned on and positioned in your bra, press the Play/Pause button to start pumping.

Modes:

• The ELVIE PUMP EP01 has two modes: Stimulation and Expression. It will always start in Stimulation mode, which is a faster pumping rhythm to stimulate milk let-down.

• The pump will automatically switch to Expression mode either when it detects milk has started to flow or after approximately two minutes.

Switching sides: If you are switching the pump from one breast to the other, press the Side Selector while the pump is paused. When you restart the pump on your other breast, it will start in Stimulation mode.

Intensity settings:

• The ELVIE PUMP EP01 has seven intensity settings. Once you can feel the suction on your nipple, use the + and – buttons to adjust the intensity to your preferred setting in both modes.

• When you reach the maximum or minimum intensity setting, the Play/Pause button will flash three times.

Changing the Bottle:

The ELVIE PUMP EP01 will automatically pause when the Bottle is full, indicated by the Bottle Light. You must empty the Bottle before resuming your session. Press the Bottle Release to separate the full Bottle from the Hub. Replace it with an empty Bottle or pour your expressed milk into another container, then click the empty Bottle back onto the Hub.

Ending your session:

1. Press Play/Pause to stop pumping.

2. Unclip your bra and use your finger to break the seal around your nipple to avoid nipple damage.

3. Remove the ELVIE PUMP EP01 from your bra.

4. Press the Power button to switch it off.

After each use, clean the washable components as advised.

Storing your milk:

You may store your expressed milk in the Bottle using the provided Lid. Both the Bottle and Lid are fridge and freezer safe. Always make sure you remove the Bottle from the Hub before storing.

How to store the ELVIE PUMP EP01:

Between sessions, please store your ELVIE PUMP EP01 out of direct sunlight and ensure the washable parts are dry. Keep it out of reach of children. Recharge immediately after finishing your pumping session if the Battery Light is on.

Long-term storage:

To preserve the lifespan of your pump, charge it using the provided Charging Cable and store it out of direct sunlight. Repeat this every 6 months as required. When removing from storage, plug the Charging Cable into your ELVIE PUMP EP01 and fully charge for approximately two hours. The washable parts will require cleaning and drying before long-term storage and should be stored out of direct sunlight to avoid discoloration.

Transport: While traveling, use the Charging Cable provided and pair with the appropriate power source for your current location. Please check with the airline prior to travel for advice on carrying and using the ELVIE PUMP EP01 while flying. Transport conditions are Temperature: -20 to +60°C / -4 to +140°F and Relative humidity: 15 to 90%.

Storage: Storage conditions are Temperature: -20 to +60°C / -4 to +140°F, Relative humidity: 15 to 90%, and Ambient pressure: 90 to 106 kPa.

Disposal: The ELVIE PUMP EP01 contains a rechargeable lithium polymer battery. Please dispose of the Hub at a designated collection point for the recycling of waste electrical and electronic equipment. The appropriate disposal will help conserve natural resources and ensure that it is recycled in a manner that protects human health and the environment.

• This is a single-user product. Use by more than one person may present a health risk and voids the warranty.

• It is recommended you consult with a licensed healthcare professional before using the ELVIE PUMP EP01 if you have an active implanted device that would be affected by a magnetic field (e.g. pacemaker, implantable cardioverter defibrillator).

• Inspect for damage, clean and sterilize washable components that come into contact with your breast and breast milk prior to first use and after every use.

• During normal use, areas of the pump may warm up. If your pumping environment is at the upper operating temperature limit (+30°C / +86°F) for the maximum session time (40 minutes), the temperature of the Breast Shield may reach up to +43°C / +109°F.

• When the pump is pumping it will automatically stop after 40 minutes. It is recommended to leave the pump for 60 minutes before using it again.

• The black semicircle on the base of the Hub uses infrared (IR) energy to monitor milk volume. Ensure this semicircle does not come into direct contact with skin while pumping.

• Do not store wet or damp parts, as mold may develop. Do not immerse the Hub or Charging Cable in water or other liquids. Wipe with a clean, damp cloth.

• This product contains small parts and a cable that may present a hazard. Keep out of reach of children.

• Only use Elvie manufactured parts, including the Charging Cable; do not substitute.

• It is recommended to use an adapter compatible with both IEC 60601-1 and your regional power source. The pump must only be used with chargers that are fully compliant with relevant USB Specifications: USB 2.0 (5V, 500mA), USB 3.0/3.1 (5V, 900mA), USB Battery Charging (BC) 1.2 (5V, 1.5A).

• Do not drop or insert any foreign object into any openings on the Hub and always close the Charging Cap after charging.

• Never operate an ELVIE PUMP EP01 if it has been damaged, is not working properly, or has been dropped into water. If damage is found, immediately discontinue use.

• If the package appears damaged or tampered with before use, do not use.

• The pump and its components are not heat-resistant. Keep away from heat sources.

• Do not use flammable materials while using or charging the pump.

• The pump should not be used while lying down or engaging in strenuous exercise. Do not use while sleeping or overly drowsy.

• Do not wear the pump when not pumping. Do not attempt to reset during use. Do not use while driving or operating heavy machinery.

• Pumping can induce labor. Do not pump until after giving birth. If you become pregnant while breastfeeding or breast pumping, consult with a licensed healthcare professional before continuing.

• The pump will not work when connected to the charger; always disconnect from the charger and close the Charging Cap before use.

• Using a breast pump should not cause pain. If excessive discomfort or pain is felt, stop pumping, break the seal around your nipple and discontinue the session.

• Always ensure you are using the right sized Breast Shield.

• Contact your healthcare professional if you express minimal or no milk, or if expression is painful. If your breast becomes swollen, hot and/or painful, seek immediate advice.

• There are no internal serviceable parts. The battery is not replaceable.

• Wash your hands thoroughly with soap and water before touching the pump, its components or your breasts. Only use drinking-quality tap water or bottled water for cleaning.

• Do not use harsh chemicals to clean the Breast Shield, Bottle, Valve, Spout or Seal.

• If stored at extreme temperatures, allow 24 hours for the pump to reach normal operating temperatures before use.

• Do not expose the pump or its components to direct sunlight.

To perform a factory reset:

1. Turn the ELVIE PUMP EP01 on.

2. Press and hold both the ‘+’ and ‘-‘ intensity buttons simultaneously for 5 seconds.

3. The Play/Pause and side LEDs will flash while the pump is resetting. The LEDs and the pump will then turn off.