medela 101044095 B Mobile Double Electric Breast Pump User Manual

medela 101044095 B Mobile Double Electric Breast Pump

Product Information

Specifications

• Product Name: Freestyle Hands-free Electric Breast Pump
• Model: Freestyle
• Available Languages: English, Spanish, French

Intended Purpose
The Freestyle Hands-free Electric Breast Pump is designed to assist lactating mothers in expressing breast milk for feeding their babies.

Indications for Use

The device is intended for use by lactating mothers who wish to express and collect breast milk for feeding their babies.

Contraindications
The device should not be used by individuals who have infections or open wounds on their breasts. It is also not recommended for individuals with certain medical conditions. Please consult a healthcare professional before using the device if you have any concerns.

Product Description

Description of the Device

The Freestyle Hands-free Electric Breast Pump is a compact and
portable device that allows for convenient and efficient expression
of breast milk. It consists of a motor unit, collection cups,
breast shields, and other accessories.

Your Breast Pump System Features

• Hands-free operation for convenience
• Adjustable suction levels for personalized comfort
• Rechargeable battery for portability
• Easy-to-clean components

Product Usage Instructions

Important Safety Information
Please read all instructions before using this product and keep them for future reference. The following symbols and signal words are used to indicate the significance of the warnings:

• WARNING: Can lead to serious injury or death.
• CAUTION: Can lead to minor injury. Can lead to material damage (not related to personal injury).
• NOTICE: Useful or important information that is not related to safety.

When using electrical products, especially when children are present, always follow basic safety precautions. If any issues or malfunctions occur, unplug the device from the electrical outlet and contact the manufacturer. To avoid health risks and reduce the risk of severe injury, it is recommended to consult with a licensed healthcare professional before using the breast pump while breastfeeding or breast pumping. Breast milk does not reduce or remove the risk of transmitting viruses to your baby. Close supervision is necessary when using the breast pump or accessories near children.

To avoid health risks and reduce the risk of injury, it is important to properly clean and maintain the device. If any damage is observed, discontinue use and contact the manufacturer.

Getting Started

First Steps
Before using the Freestyle Hands-free Electric Breast Pump for the first time, ensure that all components are clean and in good condition. Refer to the cleaning instructions provided in section 6.

Powering Your Breast Pump
The breast pump can be powered using the rechargeable battery or by connecting it to a power outlet using the included adapter. Ensure that the battery is charged or the power adapter is connected before use.

Charging the Battery
If using the rechargeable battery, connect the power adapter to the breast pump and plug it into a power outlet. Allow the battery to charge fully before using the breast pump. The charging time may vary depending on the battery level.

Disassembling Your Collection Cups
Before cleaning or assembling the breast pump, disassemble the collection cups by removing them from the motor unit. Follow the instructions provided in section 5.

Cleaning

Cleaning Overview
Proper cleaning of the breast pump is essential for maintaining hygiene and preventing contamination. Follow the cleaning instructions provided in section 6.

Washing
Wash all components of the breast pump system with warm, soapy water after each use. Use a soft brush to clean hard-to-reach areas. Rinse thoroughly and allow the components to air dry before reassembling.

Sanitizing
To ensure optimal cleanliness, it is recommended to sanitize the breast pump components regularly. Refer to section 6.3 for detailed sanitization instructions.

Assembling Your Breast Pump

Selecting the Correct Breast Shield Size
The correct breast shield size is important for comfortable and effective pumping. Refer to the instructions provided in section 7.1 for guidance on selecting the appropriate size. If unsure, visit www.medela.com or consult a lactation consultant/breastfeeding specialist for assistance.

FAQ

Q: Can I use the Freestyle Hands-free Electric Breast Pump if I have an infection on my breasts?
A: It is not recommended to use the breast pump if you have infections or open wounds on your breasts. Please consult a healthcare professional before using the device if you have any concerns.

Q: How often should I clean the breast pump?
A: It is recommended to clean the breast pump after each use. Follow the cleaning instructions provided in section 6 for proper cleaning and maintenance.

Q: Can I microwave or boil the breast pump components for cleaning?
A: No, microwaving or boiling the breast pump components can damage them and change the composition of breast milk. Follow the washing and sanitizing instructions provided in section 6 for effective cleaning.

Medela AG Lättichstrasse 4b 6340 Baar, Switzerland www.medela.com United States Medela LLC 1101 Corporate Drive McHenry, IL 60050 Phone 800-435-8316 or 815-363-1166 customer.service@medela.com www.medelabreastfeedingus.com Canada Medela Canada Inc. 4160 Sladeview Crescent, # 8 Mississauga, ON, L5L 0A1 Canada Phone 905-608-7272 info@medela.ca www.medela.ca

FreestyleTM Hands-free FreestyleTM Mains-libres

Electric breast pump Instructions for use

Important safety information

Please read all instructions before using this product. Keep these instructions for future reference.

Warnings identify all instructions that are important for safety. Failure to observe these instructions can lead to personal injury or damage to the product.

3

The following symbols and signal words show the significance of the warnings:

WARNING

Can lead to serious injury or death.

CAUTION NOTICE Information

Can lead to minor injury. Can lead to material damage (not related to personal injury). Useful or important information that is not related to safety.

When using electrical products, especially when children are present, basic safety precautions must always be followed.
WARNING
To avoid fire, electric shock, or serious burns: ·The breast pump should never be left unattended when plugged into a power source. ·Never operate an electrical device if it has a damaged cord or plug, if it is not working
properly, if it has been dropped or damaged, or dropped into water. If damage is found, immediately discontinue use of power adaptor and call Medela Customer Service. ·Do not use an electrical product that has been exposed to water or other liquids including: ­ Do not use while bathing or showering. ­ Never place or drop into water or other liquids. ­ Do not run water over the breast pump. ­ If an electrical product has been exposed to water or other liquids, do not touch and, if
possible, unplug the device from electrical outlet, turn off and contact the manufacturer.

WARNING

To avoid health risks and reduce the risk of severe injury:

·This is a single-user product. Use by more than one person may present a health risk and

voids the warranty.

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·Do not use the breast pump while operating a moving vehicle. ·Pumping may 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.

·If infected with Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV), pumping

breast milk will not reduce or remove the risk of transmitting the virus to your baby through

your breast milk.

·Wash all parts that come into contact with your breast and breast milk after every use.

·The tubing poses a risk of strangulation when being played with and small parts may be

swallowed by toddlers.

Close supervision is necessary when the breast pump or accessories are used in the vicinity

of children.

CAUTION
To avoid fire or burns: ·Make sure the voltage of the power adaptor is compatible with the power source.
See chapter 18 for technical specifications. ·Always unplug electrical products immediately after use except for when charging. ·Do not place or store the product where it can fall into water. ·The breast pump and accessories are not heat-resistant. Keep away from heated
surfaces or open flames. ·Do not use near flammable materials.

CAUTION

To avoid health risks and reduce the risk of injury:

·Before each use visually inspect the individual components for cracks, chips, tears,

discoloration or deterioration. In the event that damage to the device is observed,

please discontinue use until the parts have been replaced. ·This product cannot be serviced or repaired. Do not repair it yourself. Do not modify

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the device.

·Never use a damaged device. Replace defective or worn parts.

·Use the breast pump only for its intended purpose as described in these instructions

for use.

·Do not use the breast pump while sleeping or overly drowsy.

·If tubing becomes moldy, discontinue use and replace tubing.

·Do not microwave or boil breast milk. Microwaving can cause severe burns to baby’s

mouth from hot spots that develop in the milk during microwaving (microwaving or

boiling can also change the composition of breast milk).

·Clean and sanitize all parts that come into contact with your breast and breast milk

prior to first use.

·Only use Medela recommended parts with your breast pump.

·If pumping is uncomfortable or causing pain, turn the unit off, break the seal between

the breast and the breast shield with your finger and remove the breast shield from

your breast.

·While some discomfort may be felt when first using a breast pump, using a breast pump

should not cause pain. If you are unsure about correct breast shield sizing please visit

www.medela.com or see a lactation consultant/breastfeeding specialist who can help

you get a proper fit.

·Contact your healthcare professional or breastfeeding specialist if you can express

only minimal or no milk or if expression is painful. See chapter 7.1 for more information.

NOTICE
Take appropriate care in handling bottles and components: ·Plastic bottles and parts become brittle when frozen and may break when dropped. ·Bottles and parts may become damaged if mishandled (e.g., dropped, over-tightened,
or knocked over). ·Do not use the breast milk from bottles or components that show signs of damage.

Contents

1. Important safety information

3

2. Intended purpose

8

2.1 Indications for use

8

6

2.2 Contraindications

8

3. Product description

8

3.1 Description of the device

8

3.2 Your breast pump system features

8

4. Getting started

9

4.1 First steps

9

4.2 Powering your breast pump

9

4.3 Charging the battery

10

5. Disassembling your collection cups

10

6. Cleaning

11

6.1 Cleaning overview

12

6.2 Washing

13

6.3 Sanitizing

14

6.4 Cleaning the motor unit

15

7. Assembling your breast pump

16

7.1 Selecting the correct breast shield size

16

7.2 Assembling the collection cups

16

7.3 Preparing for single pumping

17

7.4 Preparing for double pumping

17

7.5 Placing collection cups within your bra

17

8. Operating your breast pump

18

8.1 Terms and designations

18

8.2 Operating and display elements

18

8.3 Power and battery status display

19

8.4 Bluetooth® connectivity

19

8.5 Delayed start

20

9. Expressing your breast milk

21

10. Handling of breast milk

22

10.1 Removing the collection cups from your bra

22

10.2 Pouring milk from collection cups

22

10.3 General storage guidelines

22

10.4 Freezing

23

10.5 Thawing

23

10.6 Feeding breast milk

24

11. Maintenance and care
11.1 Power adaptor care
11.2 Battery maintenance
11.3 Long-term storage
12. Troubleshooting 13. Ordering information 14. Warranty 15. Disposal 16. Meaning of symbols 17. International regulations
17.1 Electromagnetic compatibility (EMC)
17.2 Radio transmission
18. Technical specifications

25

25

25

26

27 29

7

30

31

32

35

35

39

40

2. Intended purpose
2.1 Indications for use
The FreestyleTM Hands-free breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Freestyle Hands-free breast pump 8 is intended for a single user. The breast pump is intended to be used in a home environment.
2.2 Contraindications
There are no known contraindications for the Freestyle Hands-free breast pump.
3. Product description
3.1 Description of the device
The Freestyle Hands-free breast pump is a personal-use electric breast pump that includes 2-Phase Expression technology and is capable of single and double pumping. Mode of operation: Continuous. The operating life of the breast pump is 250 hours.
3.2 Your breast pump system features
Refer to figure ¢1 on the foldout pages. ¢1-01 Hands-free In-bra Collection Cups
¢1-01-1 Breast shield 21 mm (2pcs) (Applied part) ¢1-01-1 Breast shield 24 mm (2pcs) (Applied part)
¢1-01-2 Nipple Tunnel ¢1-01-3 Yellow membrane (2pcs)
¢1-01-4 Alignment tab ¢1-01-5 Valve ¢1-01-6 Outer shell (2pcs) ¢1-01-7 Pouring spout ¢1-01-8 Tubing connection port ¢1-02 Tubing ¢1-02-1 Short ends of tubing (connects to collection cups) ¢1-02-2 Long end of tubing (connects to motor unit) ¢1-03 Motor unit (Applied part) ¢1-04 Power adaptor with cable
For ordering information about accessories see chapter 13.
All pictures shown in these instructions are for illustration purpose only. The actual product may vary due to local differences or product enhancement. Medela reserves the right to substitute any component or accessory with a replacement of equivalent performance.

4. Getting started

4.1 First steps

To be ready for expressing milk, do the following before using your breast pump for the first time:

1. Charge the battery of your Freestyle Hands-free breast pump for two hours ­

see chapter 4.3. 2. Separate all parts that are exposed to the breast or breast milk prior to cleaning ­

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see chapter 5.

3. Please ensure to boil all parts of the collection cups before first use ­ see chapter 6.2 and 6.3.

4.2 Powering your breast pump
There are two ways to power your breast pump for your pumping session:

By the rechargeable battery

By the power adaptor/cable

or

freestyle

freestyle

Before first time use, charge the breast pump battery for two hours with the power adaptor. Æ The battery display shows all three
bars when charging is complete. For details on the battery display see chapter 8.3.

Supply socket Plug the power cable into the supply socket on top of the motor unit.
For details on powering your breast pump/ charging the battery see chapter 4.3.

4.3 Charging the battery WARNING
Only use the power adaptor and cable that came with the breast pump. An inadequate power source or cable may result in a fire hazard, electric shock or malfunction equipment 10 due to overvoltage. The warranty is only valid when using the Medela power adapter to charge your pump.
Refer to figure ¢2 on the foldout pages. Charge the battery for two hours before using the breast pump for the first time. 1. ¢2-01 Connect the power cable to the motor unit. 2. ¢2-02 Connect the power cable to the power adaptor. 3. ¢2-03 Plug the power adaptor into a wall outlet.
Æ The battery display shows all three bars when charging is complete. For details on the battery display see chapter 8.3.
Information
You can use the breast pump while charging the battery. However, it will charge in a slower mode when the pump is running.
5. Disassembling your collection cups
Refer to figure ¢3 on the foldout pages. 1. ¢3-01 Open the collection cup using the tabs at the bottom. 2. ¢3-02 Remove the yellow membrane from the breast shield.

6. Cleaning
It is important you do the following before using your breast pump for the first time: Disassemble all parts & clean following your breast pump cleaning instructions. For additional cleaning guidelines see the Center for Disease Control website: https://www.cdc.gov/healthywater/hygiene/healthychildcare/infantfeeding/breastpump.html (U.S). 11

Supplies needed: ·Dish soap ·Clean soft brush ·Clean wash basin or dishwasher ·Drinking-quality water ·Clean pot for boiling water

Parts to wash and sanitize: ·Breast shields · Outer shells · Yellow membranes

CAUTION
Separate and wash all parts that are exposed to breast milk immediately after use. This will help to remove breast milk residue and prevent growth of bacteria. ·Wash hands thoroughly with soap and water. ·Only use drinking- quality tap water or bottled water for cleaning. ·Do not place collection cup parts directly in the sink to rinse or wash. Use a clean
wash basin used only for infant items. ·Do not use a dish towel to rub or pat items dry. ·Do not use disinfectants for cleaning.

NOTICE
Medela has a closed system so milk cannot get into the tube when the pump is used as instructed. Do not clean or rinse the tubing under any circumstance. · Inspect the tubing before use. If you find
condensation, breast milk and mould in the tubing, discontinue use and replace tubing. Refer to chapter 13 for ordering information. · Do not run the breast pump with wet tubing; doing so will cause damage to your breast pump.
NOTICE
Pay attention to the following: ·Take care not to damage parts of the collection cups during cleaning. ·Store the dry collection cups in a clean bag/container until next use. ·Do not store wet or damp parts as mold may develop. ·If you notice a white residue on your collection cup parts after boiling, your water
may have a high mineral content. Remove residue by wiping parts with a clean towel and allow to air dry. ·Distilled water is recommended when boiling parts to prevent substantial mineral build-up over time, which may compromise the parts.

6.1 Cleaning overview
Washing and sanitizing are two different activities. They must be done separately to protect you and your baby, and to maintain the performance of your breast pump. Wash ­ To clean the surfaces of the parts by physically removing milk residues and other possible contaminants. 12 Sanitize ­ To efficiently lower the number of germs that may be present on the surfaces of the washed parts.

Breast shield Outer shell

Yellow membrane

When to clean

Before first use After each use Once per day after use

Tubing

Disassemble the parts according to chapter 5 Wash the parts according to chapter 6.2 Sanitize the parts according to chapter 6.3
Disassemble the parts according to chapter 5 Wash the parts according to chapter 6.2
Disassemble the parts according to chapter 5 Wash the parts according to chapter 6.2 Sanitize the parts according to chapter 6.3
Motor unit

freestyle
When to clean

As needed

Do not clean or rinse the

Wipe with clean, damp towel.

tubing under any circumstance. Refer to chapter 6.4.

6.2 Washing

Refer to figure ¢4 on the foldout pages.

Rinse and wash by hand

Wash in dishwasher

(before first use and after each use)

(maximum once per day)

or

13

Do not place the parts directly in the kitchen sink for rinsing and washing. Use a dedicated wash basin for infant items. 1. Rinse the disassembled parts,
except for the tubing, with cold clear drinking-quality water (approx. 68 °F/20 °C). 2. Clean these parts with plenty of warm, soapy water (approx. 86 °F/30 °C). Use a commercially available dish soap and clean soft brush. 3. Rinse the parts with cold clear drinking-quality water for 10 to 15 seconds (approx. 68 °F/20 °C). 4. Allow to completely dry after washing.

1. Place the disassembled parts, except for the tubing, on the top rack or in the cutlery section. Use a commercially available dishwashing detergent.
2. Rinse the yellow membrane under running water after dishwashing.
3. Allow to completely dry after washing.
i Information
If using the dishwasher, parts may become discolored. This will not impact the functioning of the parts. Do not routinely wash the tubing.

Drying
1. Allow to air-dry on a clean, unused dish towel or paper towel.

6.3 Sanitizing

Refer to figure ¢5 on the foldout pages.

Sanitize on stovetop

(before first use and once

per day after use)

14

or

10 min

Sanitize in microwave (once per day after use)

1. Cover the disassembled, washed parts, except for the tubing, with plenty of water and boil at least for 10 minutes. Ensure that the parts are not in direct contact with the bottom of the pot.
2. Allow to dry after sanitizing.

1. Use Quick Clean Micro-Steam bags in the microwave in accordance with the instructions on the bags.
2. Allow to dry after sanitizing. Refer to local website/shops for availability in your country.

Drying
1. Allow to air-dry on a clean, unused dish towel or paper towel. 2. Put the clean and dry parts in a clean storage bag or a clean environment.
Do not store parts in an airtight container/bag if moist. It is important that all residual moisture dries.

6.4 Cleaning the motor unit

Supplies needed:

Parts needed:

·Drinking-quality water

·Motor unit

·Dish soap

·Clean dish towel or paper towel

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CAUTION

To prevent electric shock and damage to the material: ·Unplug the breast pump before cleaning the motor unit. · Do not immerse the motor unit in water; do not run water
over the motor unit.

NOTICE
·Do not spray or pour liquid directly onto the pump. ·When cleaning the motor unit display, only use a damp, soft towel with mild washing-up
liquid. Other cleaners or abrasive cloths may degrade the display performance.

1. Switch the breast pump off.

freestyle

2. Unplug the breast pump from the power source.

3. Wipe the motor unit with a clean towel moistened

freestyle

with drinking-quality water.

4. Wipe the motor unit dry with a clean, dry towel.

7. Assembling your breast pump
Only use clean and dry parts for assembly. Refer to chapter 6 for cleaning.
7.1 Selecting the correct breast shield size
Make sure to use the correct breast shield size. It is an essential component of effective 16 pumping, helping to optimize milk flow.
Refer to figure ¢6 on the foldout pages. 1. Select the breast shield size by measuring the diameter of your nipple ( ¢6-01). 2. Select the breast shield size that is slightly larger than your nipple ( ¢6-02).
21 mm and 24 mm size shields are included in the pack.

For more information on breast shield sizing and other available sizes, visit www.medela.com or see chapter 13 for ordering information.

7.2 Assembling the collection cups
Only use clean and dry parts for assembly. Refer to chapter 6 for cleaning.

Parts needed: · Tubing ·Breast shield ·Motor unit

· Yellow membrane · Outer shell

CAUTION
To prevent contamination of your milk: ·Wash hands thoroughly with soap and water before touching the motor unit, parts of the
collection cups and breasts. ·Dry your hands with a fresh towel or a single- use paper towel. ·Avoid touching the inside of the collection cup components. To make sure that your breast pump works properly and safely: ·Check collection cup components for wear or damage before use. Replace if necessary. ·Always inspect all parts prior to use for cleanliness. If dirty, clean according to chapter 6. ·Only use genuine Medela parts. See chapter 13 for details.
NOTICE
To prevent damage to the breast pump, all components must be completely dry before use.

Refer to figure ¢7 on the foldout pages.

1. ¢7-01 Wash hands thoroughly with soap and water before touching the motor unit,

parts of the collection cups and breasts. Dry your hands with a clean towel.

2. ¢7-02 First assemble the valve of the yellow membrane on the front of the breast shield.

3. ¢7-03 Align the disc of the yellow membrane on the designated circular slot using the

alignment tab at the top to ensure that it is at the right place. Press around the edges to make sure it is fully assembled.

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4. ¢7-04 Insert the pouring spout into the opening on the shield.

5. ¢7-05 Push the outer shell and breast shield together tightly, ensuring it is fully sealed

all the way around until you hear a snapping sound.

6. ¢7-06 Connect the long end of the tubing to the motor unit as far as it will go.

7. ¢7-07 Connect the short end of the tubing into the tubing connection port on the

collection cup.

7.3 Preparing for single pumping
Refer to figure ¢8 on the foldout pages. 1. Assemble one collection cup as described in chapter 7.2.
¢8-01 Insert the unused tubing end into the Y-shaped tubing holder. ¢8-02 Correctly assembled system (for single pumping). 2. ¢8-03 Place the collection cup in your bra according to chapter 7.5. Start pumping as described in chapter 9.

7.4 Preparing for double pumping

Information
·Double pumping saves time and increases the nutritional value of the milk. ·For the delayed start function see chapter 8.5.

Refer to figure ¢9 on the foldout pages. 1. Assemble the two collection cups as described in chapter 7.2.
¢9-01 Correctly assembled system (for double pumping). 2. ¢9-02 Place the collection cups in your bra according to chapter 7.5.
Start pumping as described in chapter 9.

7.5 Placing collection cups within your bra
Refer to figure ¢10 on the foldout pages. 1. ¢10-01 Ensure that the nipple is centered in the tunnel of the breast shield. 2. ¢10-02 The hands-free collection cups can be worn under your regular nursing bra.
Your bra will hold the collection cup in place. If you find it uncomfortable or painful during use, try switching to a looser, more stretchy nursing bra. 3. ¢10-03 The tubing can be connected facing inwards (towards the breasts) or outwards (towards the arms) based on personal preference. Ensure that the tubing is not pinched or bent during use. 4. ¢10-04 The hands-free collection cups can be used in a vertical or slightly tilted position for better visibility of the nipple and milk ejection. The scale on the collection cup gives you an approximate indication of the volume during pumping.

8. Operating your breast pump
8.1 Terms and designations

2-Phase 18 Expression

Through research, Medela found that babies nurse in 2 phases ­ Stimulation and Expression. This research is the basis for the technology in all Medela breast pumps.

Stimulation phase Expression phase Maximum comfort vacuum Let-down

Fast sucking/pumping mode to stimulate milk flow. Slower sucking/pumping mode for gentle and efficient milk removal after milk has started flowing. Highest vacuum setting where pumping still feels comfortable. Different for every mother. The reflex that makes the milk begin to flow from the breast.

8.2 Operating and display elements
Refer to figure ¢11 on the foldout pages.

¢11-01 Control elements

¢11-02 Display elements

¢11-01-1 Let-down button ¢11-01-2 Increase vacuum button ¢11-01-3 Decrease vacuum button ¢11-01-4 Start/Pause button ¢11-01-5 On/Off button User guidance: The control and display elements are not visible at all times. When the breast pump is switched on, the active elements light up.

¢11-02-1 Bluetooth indicator ¢11-02-2 Stimulation phase indicator ¢11-02-3 Vacuum level display ¢11-02-4 Battery display ¢11-02-5 Power indicator ¢11-02-6 Expression phase indicator ¢11-02-7 Multifunction display The multifunction display shows, depending on the device state, the following information: ·Session time in seconds (first minute
of pumping), then in minutes · L1 to L9 for the vacuum level
(along with the vacuum level display) ·Pairing code (during Bluetooth connection) ·Start delay in seconds

8.3 Power and battery status display

The power indicator (lightning symbol) indicates if the power adaptor is connected. Æ If it lights up, the power adaptor is connected.

The battery display shows the state of the battery and its charging level. Æ The display of all three bars indicates that the battery is full.

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With decreasing battery capacity, fewer bars appear. Æ Two bars: approx. 75% of the capacity is remaining. Æ One bar: approx. 40% of the capacity is remaining.

Æ When the breast pump emits an audio signal and the last single bar

(flashing)

is flashing, the battery is almost empty.

(flashing) (flashing)

Æ After emitting a second audio signal while the outline of the battery display is flashing, the breast pump will stop operation and switches off completely after five seconds.
If all three bars and the outline of the battery display are flashing at the same time, this indicates that the battery is overheated or defective. See Troubleshooting (chapter 12) or call Medela Customer Service.

8.4 Bluetooth® connectivity
Bluetooth is a wireless technology for exchanging data over short distances. This can be used to connect your Freestyle Hands-free breast pump to the Medela Family smartphone app. By connecting your breast pump to the Medela Family app you can automatically transfer your pumping data (session length, phases & levels) and manually input the amount of milk expressed. To benefit from the features of the app you need to create an account in the Medela Family app.
Installing the Medela FamilyTM app
1. Download and install the Medela Family app to your mobile device. The app is available free of charge for Apple® iOS and AndroidTM operating systems.
2. Open the Medela Family app on your mobile device and register by means of the app.
Connecting (pairing) your Freestyle Hands-free breast pump
1. Make sure that Bluetooth is enabled on your mobile device. When asked, please make sure to give the app permission to use Bluetooth. Android only: When you start Medela Family you get asked if you want to give the app permission to use your Location. We don’t track the position of your phone, but this is a requirement of the smartphone’s operating system to connect to a Bluetooth device.
2. In the Medela Family app, click on “Connect pump” > “Set up a new breast pump” and follow the set-up and pairing instructions on the screen.

Saving your pumping session into the app
After you finished a session, press the power button of the breast pump to transmit the data to the Medela Family app.

Information

·By tracking your pumping sessions on the Medela Family app, you can stay up to date

with daily highlights and custom content.

·Having visibility of your pumping history gives you the opportunity to plan efficiently

20

each day and track changes in your body like an increase or decrease in milk output. ·After initial set-up, the Bluetooth indicator will automatically appear on your breast

pump, when powered on, if your paired device is near and the Medela Family app is open.

·You can pair multiple mobile devices with your Freestyle Hands-free breast pump.

·Only one mobile device at a time can interact with the Freestyle Hands-free breast pump.

·The breast pump has the ability to store your last 30 pumping sessions in its memory.

If the pump is not connected prior to session 31, your history will be overwritten with

new session data.

·When connected to the pump, your Medela Family app account will log an infinite

number of historical sessions.

·After you finished a session, press the power button on the breast pump to transmit

the data to the Medela Family app.

Removing your Freestyle Hands-free breast pump from your smartphone
1. Inside the Medela Family app go to more’ and then to pump settings. 2. Tap on the pump you want to remove and then tap onremove this pump’ button.

Information
·Removing the Freestyle Hands-free breast pump from your mobile device will not delete pumping information stored in the Medela Family app.
·If you reconnect your breast pump and mobile device, the last 30 records stored within your pump will be transferred.
To learn more, please visit www.medela.com/app.

Trademark recognition: The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc., and any use of such marks by Medela AG is under license. Apple is a trademark of Apple Inc., registered in the U.S. and other countries. Android is a trademark of Google LLC.

8.5 Delayed start
The Freestyle Hands-free breast pump features a delayed start function. With this, the pump only starts after a delay of ten seconds. This is useful in case you want to multitask and prepare yourself before pumping starts. 1. To activate the delay, press and hold the Start/Pause button for two seconds
in either standby or pause mode. Æ The breast pump emits an audio signal to indicate that the delay has started. Æ During the delay time the Start/Pause button is flashing and the multifunction
display shows the remaining time in seconds. 2. After the delay time has elapsed the breast pump starts operating.
To skip the delay, press the Start/Pause button . Æ The breast pump starts operating immediately.

9. Expressing your breast milk

CAUTION

·Do not try to express with vacuum that is too high and uncomfortable (painful). The pain,

along with potential breast and nipple trauma, may decrease milk output. ·Contact your healthcare professional or breastfeeding specialist if you can express only

21

minimal or no milk or if expression is painful.

NOTICE
Make sure that the tubing is not kinked or pinched while pumping.
Refer to figure ¢12 on the foldout pages. 1. Make sure that the collection cups are connected and positioned properly. 2. ¢12-01 Press the On/Off button on the side until the breast pump emits an audio
signal, then release the button. Æ The breast pump is now in standby mode. 3. ¢12-02 Press the Start/Pause button to start the pumping operation. Æ The breast pump begins in the stimulation phase. 4. ¢12-03 Adjust the vacuum with the Increase vacuum ( ) and Decrease vacuum ( ) buttons to find a comfortable level. 5. ¢12-04 As soon as your milk begins to flow, press the Let-down button to go to the expression phase. Æ The breast pump proceeds with the expression phase. Æ If the Let-down button is not pressed within two minutes, your breast pump will
automatically go to expression phase. 6. ¢12-05 Adjust the vacuum with the Increase vacuum ( ) and Decrease vacuum ( )
buttons to find your maximum comfort vacuum. Once you are pumping in the Expression phase , increase the vacuum level until pumping feels slightly uncomfortable (not painful), then decrease the vacuum by 1 level with the Decrease vacuum ( ) button.

Information
·Maximum comfort vacuum is the highest vacuum setting where pumping still feels comfortable. This is different for every mother.
·Stimulation should be at a comfortable vacuum level, striving for a maximum level is not necessary.
·Reassess your maximum comfort vacuum throughout your pumping experience. It may change throughout each stage of lactation.

7. When your pumping session is over, press the Start/Pause button to stop the pumping operation. Æ The breast pump stops automatically after 30 minutes if there is no user interaction with the pump.
8. Press the On/Off button on the side to switch the breast pump off.
22 Pausing
In both stimulation and expression phase the breast pump can be paused. This allows you to readjust yourself or your collection cups, or attend to your surroundings. 1. For pausing, press the Start/Pause button while the breast pump is running.
Æ The pumping operation stops and the Start/Pause button and the time display are flashing.
2. To resume pumping, press the Start/Pause button again. If you want to start a completely new pumping session, switch the breast pump off and on again by pressing the On/Off button twice.
Information
·If pumping is not resumed within two minutes, the breast pump switches off automatically. ·To resume pumping, you will need to start a new session. ·If you need to pause for more than two minutes, we recommend restarting with stimulation
phase. ·Do not forget to record milk output in the Medela Family app.
10. Handling of breast milk
10.1 Removing the collection cups from your bra
Refer to figure ¢13 on the foldout pages. 1. ¢13-01 While the pump is still running, slightly lean forward and ensure all milk from the
nipple tunnel enters the collection container. Turn off pump. 2. ¢13-02 Detach the tubing from the collection cups. 3. ¢13-03 Carefully remove the collection cups from your bra.
10.2 Pouring milk from collection cups
Refer to figure ¢13 on the foldout pages. 1. ¢13-04 Place the collection cups in an upright position on a surface where they will not
be easily knocked over. You can use the volume scale markings on the shield to read the collected milk volume. The scale on the outer shell gives you an approximate indication of the volume during pumping. 2. ¢13-05 With the rounded outer shell facing down, pour breast milk through the pouring spout into a bottle or container for storage. Do not use collection cups to store milk. Do not store assembled cups in the refrigerator. 3. Fully disassemble and clean after each use and sanitize once per day as described in chapter 5 and chapter 6.

10.3 General storage guidelines
Refer to www.medela.com for a recommendation on storing and thawing of breast milk.

Storage guidelines for freshly expressed breast milk (for healthy term babies)

Room temperature 60 to 77 °F (16 to 25 °C)

Refrigerator 39 °F (4 °C) or colder

Freezer 0 °F (­18 °C) or colder

Breast milk thawed

23

in the refrigerator

Up to 4 hours is best

Up to 3 days is best

Up to 6 months is best

At room temperature: Up to 2 hours

*Up to 6 hours for milk expressed under very clean conditions

*Up to 5 days for milk expressed under very clean conditions

*Up to 9 months for milk expressed under very clean conditions

Refrigerator: Up to 24 hours Do not refreeze!

*Guidelines for expressing milk under very clean conditions: Before expressing breast milk, mothers should wash their hands with soap and water or an alcohol-based hand sanitizer. The pump parts and pumping area must be clean. Breasts and nipples do not need to be washed before pumping. ·These guidelines for storage and thawing of breast milk are a recommendation.
Contact your lactation consultant or breastfeeding specialist for further information. ·Store breast milk in the coldest spot of the refrigerator (at the back of the glass shelf
above the vegetable compartment). ·For information on storing your breast milk, visit www.medela.com.

For information on storing your breast milk, visit BreastMilkGuidelines.com (U.S.) or https://www.womenshealth.gov/breastfeeding/pumping-and-storing- breastmilk (U.S) or Medela.ca/Breastfeeding/Moms-Journey/Storing-and-Thawing- Breast-Milk (Canada).

10.4 Freezing
NOTICE
·Repeated freeze/thaw cycles destroy the structure of the milk. Therefore, never refreeze breast milk.
·Freeze expressed breast milk in plastic food-grade bottles or milk storage bags. Do not fill the bottles or bags more than 3/4 full to allow space for possible expansion.
·Label the bottles or bags with the date and volume of expression. ·Plastic bottles and parts become brittle when frozen and may break when dropped. ·Do not use the breast milk from bottles or components that show signs of damage.

10.5 Thawing CAUTION
Do not thaw or warm breast milk in a microwave or a pan of boiling water. This helps preserve important components and prevents burns. 24 ·To preserve breast milk components, thaw the milk overnight in the refrigerator. ·Alternatively, hold the bottle or bag under warm water (max. 98.6 °F/37 °C) and use
immediately, as soon as it has been thawed.
NOTICE
Gently swirl the bottle or bag to mix any fat that has separated. Avoid shaking or stirring the milk.
10.6 Feeding breast milk
It is recommended that breastfeeding is well established prior to bottle feeding your baby. ·Always inspect the bottle, the teat and other components immediately before and after
each use. If the teat appears cracked or torn, discontinue use immediately. ·To prevent a possible choking hazard, test the strength of the teat by pulling on the end
of the teat. ·Do not attempt to enlarge the teat hole. ·Infants must not be bottle fed without adult supervision. ·Do not use the teat as a pacifier. For additional breast milk collection & storage information, please visit www.medela.com, BreastMilkGuidelines.com (U.S.) or Medela.ca/Breastfeeding /Moms-Journey/Storing-and-Thawing-Breast-Milk (Canada).

11. Maintenance and care

11.1 Power adaptor care

WARNING

If the power adaptor outer casings become loose or are separating, stop use and contact

25

Medela immediately. Separation of the casing can result in electric shock.

NOTICE
To keep your power adaptor and cable in good working condition, pay attention to the following: Do not unplug the cable or the power adaptor by pulling on the cord, but hold it by the connector housing and adaptor body.

Traveling internationally
Information
Hints on traveling with your breast pump. When traveling internationally, we recommend purchasing a travel adaptor (not included) to match the corresponding wall outlet. Please consult with the country you are visiting to find out what type of adaptor will work best. The power adaptor of the breast pump is two-pronged and does not require a grounded outlet.
11.2 Battery maintenance
Your breast pump contains a built-in (not replaceable) lithium-ion rechargeable battery.
NOTICE
In case of a completely discharged battery, the breast pump cannot be used instantly after connecting it to the power adaptor. Allow the battery to be charged for at least 15 minutes before attempting to switch the pump on.
NOTICE
·For optimum pump and battery performance, use the power adaptor that comes with the breast pump.
·Make sure that the voltage of the power adaptor is compatible with the power source.

Information

To preserve the battery life cycle:

·Keep your breast pump in a cool place.

·Recharge the battery before it completely drains. This is better for the life cycle of the battery.

26

·Fully charge the battery before storing your breast pump. Refer to chapter 8.3 for information on the battery charging state.

·If your breast pump has been stored in a hot location, it may not run on battery power

right away. To resume normal battery function, allow the breast pump to cool down for

one hour. During this time, you can power your breast pump with the power adaptor

plugged into a wall outlet.

Traveling internationally
Information
This breast pump has a lithium-ion battery. Carrying such batteries on airplanes may be restricted by the country you are visiting. Please consult with the country you are visiting to find out if there are any restrictions that pertain to traveling with lithium-ion batteries.

11.3 Long-term storage
Your breast pump contains a rechargeable battery. To preserve your breast pump, when not in use for an extended amount of time, it will automatically transition into storage mode. To remove from storage mode, plug your breast pump into an external power source and charge the battery for two hours. Do not store collection cups in assembled state over an extended period of time. Before storing your breast pump for an extended amount of time remember to:

freestyle

freestyle

Clean the collection cup (refer to chapter 6)

Clean the motor unit (refer to chapter 6.4)

Make sure that the battery is charged (see below)

It is best to fully charge the battery before storing your breast pump for an extended period of time. Refer to chapter 8.3 for information on the battery charging state.

12. Troubleshooting

In case of an unexpected behavior of your breast pump, check with the troubleshooting table if you find the issue in the column “Problem” and follow the instructions in the column “Solution”.

Troubleshooting table

Problem

Solution

27

The breast pump does not enter the standby mode after you pressed the On/Off button

·You pressed the On/Off button for too short or too long a time.
·Press the On/Off button until you hear an audio signal, then release it. If the pump is in storage mode, it will take somewhat longer (approx. one second) until the audio signal is emitted.

The display does not light up after you pressed the On/Off button

·If your pump has not been used in a while and it does not start as usual, it might be in hibernation mode.
·To reset your breast pump, press and hold the On/Off button (on the side) for seven to ten seconds.
·If there is no change, make sure that the breast pump is connected to a properly working power supply.
·If there is still no change, contact the Medela Customer Service.

The timer does not count up after you pressed the Start/Pause button

·Contact the Medela Customer Service.

The breast pump generates no vacuum (motor not working) after you pressed the Start/Pause button

·Make sure that the breast pump is switched on. ·Contact the Medela Customer Service.

The breast pump generates only constant vacuum instead of sucking cycles

·Contact the Medela Customer Service.

The breast pump stops operation or cannot be turned on (emits an audio signal and all elements of the battery display are flashing)

·The breast pump refuses operation due to battery over-heating. Allow the motor unit to cool down, then restart the breast pump.

All elements of the battery ·Charging is not possible when the battery temperature display are flashing when is too high. Allow the motor unit to cool down, then resume you are trying to charge charging. your breast pump

28

There is low or no suction

·Make sure that all collection cup components are clean and dry and that connections are secure.

·While pumping, make sure the breast shields form a complete

seal around the breast.

·When single pumping, make sure that the unused tubing end

is correctly plugged into the tubing holder.

·If suction does not improve after having followed these steps,

contact Medela Customer Service.

The breast pump is not responding as expected

·To reset your breast pump, press and hold the On/Off button (on the side) for seven seconds.
·If there is no change, contact the Medela Customer Service.

The breast pump exterior got wet

·Unplug the breast pump from the power source and switch it off.
·Dry off the exterior of the breast pump.

The breast pump has been submerged in water

·Unplug the breast pump from the power source and switch it off.
·Contact Medela Customer Service.

Data cannot be sent

·The Bluetooth function on the mobile device is turned off. Turn the Bluetooth function on and try to send the data again.
·Pairing between the two devices has not been completed. Perform pairing instructions again. Refer to chapter 8.4.
·The mobile device is too far away from the breast pump. Move the device and breast pump closer together.
·The application on the mobile device is not ready. Check the application.

If you have not resolved the problem with your breast pump or you have further questions, please contact Medela Customer Service. For contact details visit www.medela.com. Under “Contact” choose your country.

13. Ordering information
Accessories

Article number Product

Depending on your region, check local

21 mm Breast shields compatible with Medela Hands-free collection cups 24 mm Breast shields compatible with Medela Hands-free collection cups 27 mm Breast shields compatible with Medela Hands-free collection cups*

29

website/shops Y-shaped tubing compatible with Medela Freestyle Hands-free

for availability. Membrane compatible with Medela Hands-free collection cup

• If the result of expression is unsatisfactory or expression is painful, contact your lactation consultant or breastfeeding specialist. A different size of breast shield may help make expression more comfortable and effective.

In case of difficulties in finding your desired accessory, please contact Medela Customer Service. For contact details visit www.medela.com. Under “Contact” choose your country. For replacement of lost or defective parts please contact Medela Customer Service. Other Medela products are available at www.medela.com.

14. Warranty
This product is warranted by Medela, LLC to the original retail purchaser to be free from defects in material and workmanship for the period of 1 year for pump mechanism from the date of purchase. Warranty can only be claimed in the country of purchase. In the event of defect, at Medela’s option, Medela will replace this product, without charge for 30 such replacement parts. Purchaser shall bear all expense for returning this product to Medela. This warranty does not apply to any product used commercially or which has been subjected to misuse, abuse or alteration.

ANY AND ALL IMPLIED WARRANTIES, INCLUDING THE WARRANTY OF MERCHANTABILITY, ARE LIMITED TO A DURATION OF 1 YEAR FROM DATE OF PURCHASE. SOME AREAS DO NOT ALLOW LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY LASTS, SO THE ABOVE LIMITATIONS MAY NOT APPLY TO YOU. THIS WARRANTY GIVES YOU SPECIFIC LEGAL RIGHTS AND YOU MAY ALSO HAVE OTHER RIGHTS WHICH VARY FROM STATE TO STATE OR IN YOUR COUNTRY.

Before you make a claim under this warranty, it may save time and expense to call Medela Customer Service (see contacts below). You may also call this number for additional information concerning this warranty. If you wish to make a claim under this warranty, you must return this product to Medela with a return authorization number received from Medela Customer Service, prepaid, together with your dated bill of sale or other proof of purchase and a brief statement of the problem to the following address:

USA Medela LLC ­ Returns, Door 4501 1101 Corporate Dr. McHenry, IL 60050 ATTENTION: RETURNS Medela Customer Service (toll free): 1-800-435-8316

Medela Canada 4160 Sladeview Crescent Unit #8 Mississauga, ON L5L 0A1 ATTENTION: RETURNS info@medela.ca

Contact Customer Service for a return authorization number. Returns are not accepted without an authorization number.

15. Disposal

Disposal of your breast pump
At the end of its operating life, separate the parts of your breast pump and dispose of according to the following instructions.

Breast shields, outer shells, tubing and membranes

31

The parts are made of plastics that are not harmful to the environment when disposed

of as household waste. Recycle or dispose of according to local regulations.

Motor unit and power adaptor

Do not dispose of electric or electronic equipment together with unsorted municipal waste, but collect it separately. In the European Union the manufacturer or its vendor must take back waste equipment. Other countries may have similar collection and recycling systems. Dispose of the waste equipment according to local regulations. Inquire at the point of sale or contact your local authority for appropriate collection points for waste equipment. The separate collection and recycling of your waste equipment at the time of disposal will help conserve natural resources and ensure that it is recycled in a manner that protects human health and the environment.
CAUTION
Hazardous materials present in electric/electronic equipment may harm human health and the environment if the waste equipment is not disposed of properly.

16. Meaning of symbols

The following tables explain the meaning of the symbols found on the product parts and its packaging.

Symbols used in these instructions

32

General safety alert symbol, points

to information related to safety.1

Defines a relative humidity range (e.g. for operation, transport, or storage).3

Defines a temperature range (e.g. for operation, transport, or storage).2

Defines an atmospheric pressure range (e.g. for operation, transport, or storage).4

Indicates that this device contains Bluetooth wireless technology. (Trademarks of Bluetooth Special Interest Group (SIG))

Symbols on the motor unit

Indicates the location of the On/Off button.5

Identifies the manufacturer.6

Indicates the date of manufacturing.7

Indicates the part number of the device.8

Indicates the serial number of the device.9

Indicates the degree of protection against ingress of foreign objects and moisture.10

Indicates compliance with international requirements for protection from electric shock (Type BF applied parts).11

Do not dispose of electric/electronic devices together with unsorted municipal waste (dispose of the device in accordance with local regulations).12 *

Indicates the compliance with additional USA and Canada safety requirements for medical electrical equipment.13

Indicates that this device contains Bluetooth wireless technology. (Trademarks of Bluetooth Special Interest Group (SIG))

Read and follow the instructions for use.14

Indicates direct current.16

Indicates the compliance with the requirements of the Federal Communications Commission.15

The CE mark indicates conformity with the European applicable directive.*

The Regulatory Compliance Mark indicates the compliance with Australian EMC and radio transmission requirements.*

Symbols on the power adaptor

Indicates alternating current.17

Indicates direct current.16

Indicates the polarity of the USB power output.18 Indicates that the device is for indoor use only.20

Indicates that the device is a Class II electrical appliance (double insulated).19
33
Indicates the efficiency level for external power supplies.21

Indicates the compliance with the requirements of the Federal Communications Commission.15

The NOM (Norma Oficial Mexicana) mark indicates that the product is found to be in compliance with the applicable Mexican requirements.

The UL LISTED mark indicates that the product is manufactured in compliance with UL safety requirements for USA and Canada (USA: UL60950-1, CAN: CSA C22.2 NO. 60950-1).

Symbols on the packaging
Identifies the manufacturer.6 Indicates the part number of the product.8 Defines the temperature range for transport or storage.2 Defines the atmospheric pressure range for transport or storage.4
The packaging contains products intended to come in contact with food according to Regulation (EC) No 1935/2004.
The CE mark indicates conformity with the European applicable directive. Read and follow the instructions for use.14 Indicates the lot/batch number.27 Indicates the serial number of the device.9

Keep away from sunlight.23

Contains fragile goods. Handle with care.22 Defines the relative humidity range for transport or storage.3 Keep away from rain. Keep in dry conditions.24 Do not dispose of electric/electronic devices together with unsorted municipal waste (dispose of the device in accordance with local regulations).12 * Indicates the compliance with the requirements of the Federal Communications Commission.15 Indicates that the package is capable of being recycled.25

Indicates the date of manufacturing.7

20

Indicates the material from

which an item is made.26 *

PAP

References

1 IEC 60601-1, Medical electrical equipment ­ Part 1: General Requirements for basic safety and essential performance,

Table D.2 Symbol 2 General warning sign.

2 ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements,

Clause 5.3.7 Temperature Limit / ISO 7000-0632, Graphical symbols for use on equipment, Temperature Limit.

3 ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements,

Clause 5.3.8 Humidity Limit / ISO 7000-2620, Graphical symbols for use on equipment, Humidity Limit.

4 ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements,

Clause 5.3.9 Pressure Limit / ISO 7000-2621, Graphical symbols for use on equipment, Pressure Limit.

34

5 IEC 60601-1, Medical electrical equipment ­ Part 1: General Requirements for basic safety and essential performance, Table D.1 Symbol 29 Stand-by. 6 ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements,

Clause 5.1.1 Manufacturer.

7 ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements,

Clause 5.1.3 Manufacturing Date / ISO 7000-2497, Graphical symbols for use on equipment, Date of manufacture.

8 ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements,

Clause 5.1.6 Article number / ISO 7000- 2493, Graphical symbols for use on equipment, Catalogue number.

9 ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements,

Clause 5.1.7 Serial number / ISO 7000-2498, Graphical symbols for use on equipment, Serial number.

10 IEC 60601-1, Medical electrical equipment ­ Part 1: General Requirements for basic safety and essential performance,

Table D.3 Symbol 2 IP Code IEC 60529: Degrees of protection provided by enclosures (IP Code).

11 IEC 60601-1, Medical electrical equipment ­ Part 1: General Requirements for basic safety and essential performance,

Table D.1 Symbol 20 Type BF applied parts.

12 EN 50419, Marking of Electrical and Electronic Equipment in accordance with Article 11(2) of Directive 2002/96/EC (WEEE).

13 TÜV (Technical Inspection Association) mark indicates that the product is manufactured in compliance with UL safety requirements for USA

and Canada (USA: UL60950-1, CAN: CSA C22.2 NO. 60950-1).

14 IEC 60601-1, Medical electrical equipment ­ Part 1: General requirements for basic safety and essential performance,

Table D.2 Symbol 10 Refer to instruction manual/booklet.

15 Code of Federal Regulations, Title 47, Part 15b / 15 c.

16 IEC 60601-1, Medical electrical equipment ­ Part 1: General Requirements for basic safety and essential performance,

Table D.1 Symbol 1 Direct current.

17 IEC 60601-1, Medical electrical equipment ­ Part 1: General Requirements for basic safety and essential performance,

Table D.1 Symbol 4 Alternating current.

18 IEC 60950-1 Information technology equipment – Safety – Part 1: General requirements, Clause 1.7.1 / IEC 60417 Graphical symbols for use

on equipment

19 IEC 60601-1, Medical electrical equipment ­ Part 1: General Requirements for basic safety and essential performance,

Table D.1 Symbol 9 Class II equipment.

20 IEC 60417-5957, Graphical symbols for use on equipment, For Indoor use only.

21 US Department of Energy Requirement, 10 CFR Part 430.

22 ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements,

Clause 5.3.1, Fragile, handle with care / ISO 7000-0621, Graphical symbols for use on equipment, Fragile, handle with care.

23 ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements,

Clause 5.3.2 Keep away from sunlight / ISO 7000-0624, Graphical symbols for use on equipment, Keep away from sunlight.

24 ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements,

Clause 5.3.4, Keep away from rain / ISO 7000-0626, Graphical symbols for use on equipment, Keep away from rain.

25 ISO 7000-1135, Graphical symbols for use on equipment, General symbol for recovery/recyclable.

26 97/129/EC, Commission Decision establishing the identification system for packaging materials.

27 ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements,

Clause 5.1.5 Batch code / ISO 7000-2492, Graphical symbols for use on equipment, Batch code.

• These symbols are not applicable for the US, Canada, Mexico market.

17. International regulations

17.1 Electromagnetic compatibility (EMC)

The Freestyle Hands-free breast pump is intended to be used in a home environment and

is EMC-tested in conformity with the requirements of the standard IEC 60601-1-2:2014 4th

Edition according to clause 7 and 8.9.

35

The breast pump needs special precautions regarding EMC and needs to be installed and

put into service according to the EMC information provided in these instructions for use.

Portable and mobile RF communications can affect the breast pump.

WARNING
To prevent malfunction resulting from electromagnetic interference: ·The electric breast pump Freestyle Hands-free should not be used adjacent to or stacked
with other equipment. If adjacent or stacked use is necessary, the electric breast pump Freestyle Hands-free should be observed to verify normal operation in the configuration in which it will be used. ·Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies, RFID can affect the electric breast pump and should be kept at a distance of at least 30 cm (12 inches) away from the device. ·Use of accessories or cables other than those provided by the manufacturer of this device could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

NOTICE
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: ·Reorient or relocate the receiving antenna. ·Increase the separation between the equipment and receiver. ·Connect the equipment into an outlet on a circuit different from that to which the receiver
is connected. ·Consult the dealer or an experienced radio/TV technician for help.

Guidance and manufacturer’s declaration ­ electromagnetic emissions This breast pump is intended for use in the electromagnetic environment specified below. The customer or the user of the breast pump should assure that it is used in such an environment.

36 Emission tests RF Emissions CISPR 11

Compliance Group 1

Electromagnetic environment ­ guidance The breast pump uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3

Class B Not applicable Not applicable

The breast pump is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Guidance and manufacturer’s declaration ­ electromagnetic immunity

This breast pump is intended for use in the electromagnetic environment specified below.

The customer or the user of the breast pump should assure that it is used in such an

environment. The Freestyle Hands-free breast pump has no essential performance but was

tested for immunity to electromagnetic disturbances and passed using the following criteria: 1. No change in mode and operation of the breast pump.

37

2. The pump can be controlled by changing the vacuum level and/or pressing the

On/Off button.

3. The Bluetooth communication may be impaired temporarily but may never be

completely interrupted in such a way that a new pairing is necessary.

Reset (The following sequence can be used to reset the device in the event of an EM Disturbance) 1. Unplug the power cable from the motor unit. 2. Unplug the power adaptor from the wall outlet. 3. Attach a breast pump set to the tubing port (if none is attached). 4. Press and hold the On/Off button for seven to ten seconds. 5. Plug the power adaptor back into the wall outlet. 6. Plug the power cable into the supply socket of the motor unit. 7. Press the On/Off button to switch the breast pump on. 8. Press the Start/Pause button to begin pumping.

Immunity test Electrostatic discharge (ESD) IEC 61000-4-2

IEC 60601 test level
+/- 8 kV contact discharge +/- 15 kV air discharge

Compliance level
+/- 8 kV contact discharge +/- 15 kV air discharge

Electromagnetic environment ­ guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 5%.

Electrical fast transient/burst IEC 61000-4-4

± 2 kV for power supply lines

± 2 kV for power supply lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

± 0.5 kV, ± 1 kV Line-to-line

± 0.5 kV, ± 1 kV Line-to-line

Mains power quality should be that of a typical commercial or hospital environment.

0at%0°U, 4T 5fo°r,

0.5 cycle 90°, 135°,

180°, 225°, 270°,

and 315°

a0t%0°U, 4T 5fo°r,

0.5 cycle 90°, 135°,

180°, 225°, 270°,

and 315°

Mains power quality should be that of a typical commercial or

38

Voltage dips, short interruptions and

0at%0°UT for 1 cycle

a0t%0°UT for 1 cycle

hospital environment. If the user of the breast pump requires

voltage variations on power supply input lines IEC 61000-4-11

c7y0c%lesUaTtfo5r02H5z at 0° for 30 cycles at 60 Hz at 0°

c7y0c%lesUaTtfo5r02H5z at 0° for 30 cycles at 60 Hz at 0°

continued operation during power mains interruptions, it is recommended that the breast pump be

0cy%cleUsTafot r5205H0z at 0° for 300 cycles

0cy%cleUsTafot r5205H0z at 0° for 300 cycles

powered from an uninterruptible power supply or a battery.

at 60 Hz at 0°

at 60 Hz at 0°

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

30 A/m

30 A/m

It may be necessary to position the breast pump further from sources of power frequency magnetic fields or to install magnetic shielding. The power frequency magnetic field should be measured in the intended installation location to assure that it is sufficiently low.

NOTE: UT is the a.c. mains voltage prior to application of the test level.

Table of frequencies of portable and mobile transmitters for which the recommended separation distance is 30 cm (12 inches):

Band (MHz) Service

380 – 390 TETRA 400

430 – 470

GMRS 460, FRS 460

39

704 – 787

LTE Band 13, 17

800 – 960 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5

1 700 – 1 990 GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS

2 400 – 2 570 Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7

5 100 – 5 800 WLAN 802.11 a/n

WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Freestyle Hands-free breast pump including cables specified. Otherwise, degradation of the performance of this equipment could result.

17.2 Radio transmission
FCC (USA) statement
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.
ISED (Canada) statement
This device complies with Industry Canada’s licence-exempt RSSs. Operation is subject to the following two conditions: (1) this device may not cause interference; and (2) this device must accept any interference, including interference that may cause undesired operation of the device.

18. Technical specifications

Summary of important technical specifications

Vacuum performance (at 500 m above

sea level [954.62 hPa ambient pressure])

40

-45 to -245 mmHg (-60 to -327 hPa) 45 to 111 cpm

+5°C

+35°C Operating temperature range 41 to 95 °F (5 to 35 °C)

Power adaptor (S010W0500200) country code

93% Operating humidity range (15% to 93% relative humidity)
15%

Input Output

100 to 240 V~ 50/60 Hz max. 0.4 A
70 kPa
5 V 2 A 10 W

Average efficiency

79%

-20°C

No-load power consumption

Lower than 0.1 W

Motor unit

15%

106kPa Ambient pressure range (70 kPa to 106 kPa)
+50°C Transport/storage temperature -4 to 122 °F (-20 to 50 °C)
93% Transport/storage humidity range (15% to 93% relative humidity)

Battery capacity and type Size

Min. 2750 mAh Li-ion, Size 18650 148 x 66 x 46.5 mm

Weight

273 g

Ingress protection level: IP22
Transmission standard: Bluetooth version 4.0 LE Frequency range: 2402-2480 MHz Max. power output: +4 dBm (class 2)
Materials touching skin or coming in contact with milk
·Breast shield: Polypropylene ·Outer shell: Polypropylene, Thermoplastic Elastomer ·Membrane: Silicone Not intentionally made of BPA.

References

• Breastfeeding & Pumping
• Homepage Medela | Medela
• Breastfeeding & Pumping
• Homepage Medela | Medela
• Breastfeeding Resources, Education, and Support | Medela
• cdc.gov/healthywater/hygiene/healthychildcare/infantfeeding/breastpump.html
• Pumping and storing breastmilk | Office on Women's Health

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