Freestyle Flex ™ EN Electric breast pump Instructions for use Master file (classified as medical device)
ENGLISH EN 4–51
1. Important safety information 4 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. The following symbols and signal words show the significance of the warnings: WARNING Can lead to serious injury or death. CAUTION Can lead to minor injury.
WARNING To avoid health risks and reduce the risk of severe injury: • Do not use the Freestyle Flex breast pump while operating a moving vehicle. • Pumping can induce labour. Do not pump until after giving birth. If you become pregnant while breastfeeding or breast pumping, consult with a licensed healthcare professional before continuing.
Important safety information (cont.) 6 CAUTION To avoid health risks and reduce the risk of injury: • This is a single-user product. Use by more than one person may present a health risk and voids the warranty. • This product cannot be serviced or repaired. Do not repair yourself. Do not modify 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 instruction for use.
Contents 1. Important safety information 2. Intended purpose 2.1 4 9 Indications for use 9 3. Product description 9 3.1 3.2 Description of the Freestyle Flex breast pump Your breast pump system includes 4. Getting started 4.1 4.2 First steps Powering your breast pump 5. Cleaning 5.1 5.2 5.3 5.4 5.5 5.6 Cleaning overview Disassembling Washing Sanitizing Cleaning the motor unit Cleaning the tubing 6. Breast shield sizing 6.1 6.
11. Storing and thawing breast milk 11.1 11.2 11.3 11.4 11.5 General storage guidelines Storing breast milk in a Medela cooler bag Freezing Thawing Feeding breast milk 12. Maintenance and care 37 37 37 38 38 38 39 12.1 Power adaptor care 12.2 Battery maintenance 12.3 Long-term storage 39 39 40 13. Troubleshooting 14. Ordering information 15. Warranty 16. Disposal 17. Meaning of symbols 18. International regulations 41 43 44 45 46 49 18.1 Electromagnetic compatibility (EMC) 18.
2. Intended purpose 2.1 Indications for use The Freestyle Flex breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Freestyle Flex breast pump is intended for a single user. 3. Product description 3.1 Description of the Freestyle Flex breast pump The Freestyle Flex is a personal-use electric breast pump that includes 2-Phase Expression technology and is capable of single and double pumping.
Product description (cont.) 10 3.2 Your breast pump system includes 2x PersonalFit Flex breast shield (21 mm) (Applied Part) 2x PersonalFit Flex connector 2x PersonalFit Flex breast shield (24 mm) (Applied Part) 2x Membrane For other breast shield sizes, see chapter 6 2x Connector body 4x Bottle 1x Tubing 1x Motor unit Short ends of tubing (connect to one or two connectors) Tubing holder Long end of tubing (connects to motor unit) For ordering information about accessories see chapter 14.
1x power adaptor with cable 4x Lid 2x Bottle stand 1x Bag 1x Cooler bag 1x Ice pack (included in cooler bag) For ordering information about accessories see chapter 14. 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 12 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 Flex breast pump for two hours – see section 8.3. 2. Separate all parts that are exposed to the breast or breast milk prior to cleaning – see section 5.2. 3. Clean and sanitize the parts – see section 5.3 and 5.4. 4.
5. Cleaning Supplies needed: • Mild dish soap • Clean soft brush • Clean wash basin • Drinking-quality water • Clean pot for boiling water Parts to wash or sanitize: • Breast shields • Breast milk bottles • Lids • Connectors • 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.
Cleaning (cont.) 14 5.1 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 contamination. Sanitize – To kill living organisms, such as bacteria or viruses, that may be present on the surfaces of the parts.
5.2 Disassembling * 15 Before first use Remove and dispose of the protective cover* from the breast shield. After each use Disassemble the pump set into its individual parts (breast shield, connector and milk bottle) as follows: 1. Remove the breast shield from the connector. 2. Open the back cap of the connector by squeezing both flaps and swiveling the cap upwards. 3. Remove the membrane from the connector body. 4. Separate the milk bottles, lids and bottle stands.
Cleaning (cont.) 16 5.3 Washing Washing is important for hygiene and serves to clean the surfaces of the parts by physically removing contamination. Wash the parts either by hand or in a dishwasher. Before first use and after each use Rinse and wash by hand Do not place the parts directly in the kitchen sink for rinsing and washing. Use a dedicated wash basin for infant feeding items. 1. Rinse the disassembled parts, except for the tubing, with cold, clear drinking-quality water (approx. 68 °F/20 °C).
5.4 Sanitizing 17 Sanitizing is important for hygiene and serves to kill living organisms, such as bacteria or viruses. Boil the parts either on the stovetop or use Quick Clean microwave bags. Before first use and once per day Sanitize on stovetop or Sanitize in microwave 5min 1. Cover the disassembled parts, except for the tubing, with water and boil at least for 5 minutes. 2. Allow to dry after sanitizing. 1. Use Quick Clean* bags in the microwave in accordance with the instructions on the bags.
Cleaning (cont.) 18 5.5 Cleaning the motor unit Supplies needed: • Drinking-quality water • Mild dish soap • Clean dish or paper towel Parts needed: • Motor unit CAUTION • 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 dish soap.
5.6 Cleaning the tubing 19 Normally, cleaning of the tubing is not necessary. Only if it is dirty or if milk is present it is necessary to wash the tubing as described in these instructions. Supplies needed: • Drinking-quality water • Mild dish soap Parts needed: • Tubing NOTICE • If the tubing becomes mouldy, discontinue use and replace tubing. Refer to chapter 14 for ordering information. • Do not use the breast pump with wet tubing; doing so will cause damage to your breast pump.
6. Breast shield sizing 20 6.1 Selecting the correct Medela breast shield size Make sure to use the correct breast shield size. It is an essential component of effective pumping, helping to optimize milk flow. Understanding Medela’s breast shield sizing Pumping should not hurt. For maximum comfort and pumping efficiency, Medela offers multiple breast shield sizes*. This guide is a starting point to help determine your optimal size based on your nipple diameter.
6.2 Optimizing the breast shield size 21 • Start with the breast shield that came with your pump, or the size determined by measuring. • Center the nipple and gently hold the breast shield against the breast. • Adjust for maximum comfort vacuum (refer to chapter 9) to achieve optimum suction level. • Refer to the images below while pumping in the expression phase (after the stimulation phase). too small Areola Nipple • The nipple rubs along the side of the tunnel. • Try a larger size.
7. Assembling your breast pump 22 Only use clean and dry parts for assembly. Refer to chapter 5 for cleaning. 7.1 Assembling the pump set Parts needed: • Tubing • Motor unit • Breast shields • Breast milk bottles • Lids • Connectors • Membranes CAUTION To prevent contamination of your milk: • Wash hands thoroughly with soap and water before touching the motor unit, parts of the pump set and breasts. • Dry your hands with a fresh towel or a single-use paper towel.
3. Screw the connector onto the bottle. 4. Carefully push the breast shield into the connector body. Æ Choose a breast shield size that suits your needs. For proper sizing see chapter 6. 5. The oval breast shields can be rotated (360°) and placed in the desired position to have the most comfortable fit for you. 6. Insert the short end of the tubing into the opening of the connector lid. 7. Insert the long end of the tubing into the motor unit as far as it will go.
Assembling your breast pump (cont.) 24 7.2 Preparing for single pumping 1. Insert the unused tubing end into the tubing holder. Æ Correctly assembled system (for single pumping). 2. Place the breast shield on the breast so that the nipple is properly centerd in the tunnel. 3. Hold the breast shield and connector onto your breast with your thumb and index finger. 4. Support your breast with the palm of your hand. 5. Start pumping as described in section 8.4.
7.3 Preparing for double pumping i Information • Double pumping saves time and increases the nutritional value of the milk. • You may want to start the breast pump by means of the delayed start function, which allows you to have both hands free when pumping starts. For the delayed start function see section 10.2. • For hands-free expression you can also put on the Easy Expression Bustier* available from Medela. 1. Assemble the second pump set as described in section 7.1.
Assembling your breast pump (cont.) 26 7.4 Hands-free expression with the Easy Expression Bustier i Information The Easy Expression Bustier must be purchased separately. More information on www.medela.com. 1. Put the Easy Expression Bustier on and close it using the hook on top. 2. Leave the zip slightly open. 3. Place the breast shield on your breast under the bustier in such a way that your nipple is centerd in the tunnel of the breast shield. 4. Close the zip for secure fit of the bustier. 5.
8. Operating your breast pump 8.1 Terms and designations 27 2-Phase Expression Through research, Medela found that babies nurse in 2 phases – Stimulation and Expression. This research is the basis for the technology in most Medela breast pumps. Stimulation phase Fast sucking/pumping mode to stimulate milk flow. Expression phase Slower sucking/pumping mode for gentle and efficient milk removal after milk has started flowing.
Operating your breast pump (cont.
8.3 Charging the battery WARNING Only use the power adaptor and cable that comes with the breast pump. An inadequate power source or cable may result in a fire hazard, electric shock or malfunction of the equipment. i Information • You can use your breast pump while charging the battery. The battery will charge as soon as the breast pump is connected to a power source. However, it will charge in a slower mode when the pump is running. 1. Connect the power cable to the motor unit. 2.
Operating your breast pump (cont.) 30 8.4 Expressing your breast milk CAUTION • Do not hold the pump set by the bottle. This can lead to compression and blockage of the milk ducts and engorgement. • 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 minimal or no milk or if expression is painful.
5. Adjust the vacuum with the Increase vacuum ( ) and Decrease vacuum ( ) buttons to find a comfortable level (for maximum comfort vacuum see chapter 9). 6. 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. 7.
Operating your breast pump (cont.) 32 Pausing In both stimulation and expression phase the breast pump can be paused. This allows you to readjust yourself or your breast pump set, 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.
9. Finding your maximum comfort vacuum Once you are pumping in the Expression phase , increase the vacuum with the Increase vacuum ( ) button until pumping feels slightly uncomfortable (not painful), then decrease the vacuum slightly with the Decrease vacuum ( ) button. i Information • Maximum comfort vacuum is the highest vacuum setting where pumping still feels comfortable. This is different for every mother.
10. Special features 34 10.1 Bluetooth® connectivity Bluetooth is a wireless technology for exchanging data over short distances. This can be used to connect your Freestyle Flex breast pump via a personal device, such as a smart phone, to the MyMedela platform. By connecting your breast pump to the MyMedela platform you can automatically transfer your pumping data (session length, phases & levels) and manually input the amount of milk expressed.
5. Read the pairing code from the multifunction display and select the corresponding device in the MyMedela app. Æ After successful pairing the Bluetooth indicator on the breast pump lights up continuously. Æ If the pairing is not successful within two minutes, the breast pump will switch off automatically. i Information • By tracking your pump sessions on the MyMedela platform, you can stay on-target with daily highlights and custom content.
Special features (cont.) 36 10.2 Delayed start The Freestyle Flex 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 have your hands free when pumping starts (e.g. for holding the breast shields while double pumping). 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 is started.
11. Storing and thawing breast milk 11.
Storing and thawing breast milk (cont.) 38 11.3 Freezing NOTICE • Repeated freeze/thaw cycles destroy the structure of the milk. Therefore, never refreeze breast milk. • Freeze expressed breast milk in plastic 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.
12. Maintenance and care 12.1 Power adaptor care 39 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 i 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.
Maintenance and care (cont.) 40 i 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. • Fully charge the battery before storing your breast pump. Refer to section 8.2 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.
13. Troubleshooting In case of an unexpected behaviour 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 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.
Troubleshooting (cont.) 42 All elements of the battery display are flashing when you are trying to charge your breast pump • Charging is not possible when the battery temperature is too high. Allow the motor unit to cool down, then resume charging. There is low or no suction • Make sure that all pump set components are clean and dry and that connections are secure. • While pumping, make sure the breast shields form a complete seal around the breast.
14. Ordering information Sales article Freestyle Flex breast pump Article number Product 101037980 Freestyle Flex breast pump (with US power adaptor) Accessories Article number Product Depending on your region, check local website/shops for availability.
15. Warranty 44 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 2 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 such replacement parts. Purchaser shall bear all expense for returning this product to Medela.
16. 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, connector, tubing and accessories 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.
17. Meaning of symbols 46 The following tables explain the meaning of the symbols found on the product parts and its packaging. Symbols used in these instructions General safety alert symbol, points to information related to safety. Defines a temperature range (e.g. for operation, transport or storage). Defines a relative humidity range (e.g. for operation, transport or storage). Defines an atmospheric pressure range (e.g. for operation, transport or storage).
Symbols on the motor unit (cont.) Indicates that this device contains Bluetooth wireless technology. The Regulatory Compliance Mark indicates the compliance with Australian EMC and radio transmission requirements. The CE mark indicates conformity with the European low voltage and electromagnetic compatibility directive. Indicates direct current. Symbols on the power adaptor Indicates alternating current. Indicates direct current. Indicates the polarity of the USB power output.
Meaning of symbols (cont.) 48 Symbols on the packaging Identifies the manufacturer. Indicates the part number of the product. Contains fragile goods. Handle with care. Keep away from sunlight. Keep away from rain. Keep in dry conditions. Defines the temperature range for transport or storage. Defines the relative humidity range for transport or storage. Defines the atmospheric pressure range for transport or storage.
18. International regulations 18.1 Electromagnetic compatibility (EMC) Breast pumps are intended to be used in a hospital or home environment. The Freestyle Flex breast pump is EMC-tested in conformity with the requirements of IEC 60601-1-2:2007 3rd Edition and IEC 60601-1-2:2014 4th Edition according to clause 7 and 8.9. WARNING The electric breast pump Freestyle Flex should not be used adjacent to or stacked with other equipment.
19. Technical specifications 50 Summary of important technical specifications Vacuum performance (at 500 m above sea level [954.62 hPa ambient pressure]) -45 to -245 mmHg (-60 to -327 hPa) 45 to 111 cpm Operating temperature range 41 to 95 °F Power adaptor (Model: S010WU0500200) Operating humidity range In 100 to 240 V~ 50/60 Hz max. 0.4 A Ambient pressure range Out 5V 2A Battery capacity and type 3.7 V, 2750 mAh Li-ion Size 148 x 66 x 46.
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