Swing Maxi Flex - Breast pump MEDELA - Free user manual and instructions

USER MANUAL Swing Maxi Flex MEDELA

04–35Table of Contents

1. Intended use / Population – Contraindication 5

2. Meaning of symbols 6

7. Preparing for pumping 16

7.1 Mains operation 16

7.2 Battery operation

7.3 Assembling the pump set

8.1 Swing Flex – Preparing for single pumping 20

8.2 Swing Maxi Flex – Preparing for single pumping

8.3 Swing Maxi Flex – Preparing for double pumping

with the Easy Expression Bustier

9. Storing and thawing breast milk 28

12. Spare parts and Accessories 31

4The intended use and indications of breast pumps Breast pumps are intended to be used by lactating women in the hospital or home environment for expressing breast milk. Breast pumps are indicated to alleviate the symptoms of engorgement by expressing milk. In case of mastitis breast pumps support the healing process by removing breast milk from the affected breast. Breast pumps are indicated to relieve sore and cracked nipples and to bring out at or inverted nipples. Also breast pumps enable mothers to provide breast milk for babies who cannot feed directly at the breast for a variety of reasons such as latch-on problems, cleft palate or premature babies. Intended patient population/user Adolescent paediatric or adult lactating women. Many women nd it convenient, or even necessary, to use a breast pump to express and store their breast milk once they have returned to work, are travelling or are otherwise separated from their baby. Women are often delighted to learn that a breast pump can be used as a supplement to breastfeeding and that some pumps are designed to mimic the suckling of a nursing baby. Contraindications There are no known contraindications for the Swing Flex / Swing Maxi Flex breast pump.

1. Intended use / Population – Contraindication

55Warning Can lead to serious injury or death. Note Can lead to material damage. Caution Can lead to minor injury. Info Useful or important information that is not related to safety. Symbols on the packaging This symbol indicates that the material is part of a recovery/recycling process.This symbol indicates a carton package.This symbol indicates to keep the device away from sunlight.This symbol indicates to handle the fragile device with care.This symbol indicates the temperature limitation for operation, transport and storage.This symbol indicates the humidity limitation for operation, transport and storage.This symbol indicates the atmospheric pressure limitation for operation, transport and storage.This symbol indicates to keep the device dry.This symbol indicates that the packaging contains products intended to come in contact with food according to regulation 1935/2004.This symbol indicates unique GSI Global Trade Item Numbers (GTIN).This symbol indicates do not dispose the device together with unsorted municipal waste (for EU only).This symbol indicates to follow instructions for use. Symbols on the device This symbol indicates to follow instructions for use.This symbol indicates the compliance with the essential requirements of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.This symbol indicates the manufacturer.

2. Meaning of symbols

The warning symbol identies all instructions that are important for safety. Failure to observe these instructions can lead to injury or damage to the breast pump! When used in conjunction with the following words, the warning symbol stands for:

66This symbol indicates do not dispose the device together with unsorted municipal waste (for EU only). This symbol indicates the compliance with additional USA and Canada safety requirements for medical electrical equipment. This symbol indicates a type BF applied part. This symbol indicates manufacturer’s serial number of the device. This symbol indicates the positioning of battery cell. This symbol indicates the protection against ingress of solid foreign objects and against harmful effects due to the ingress of water. This symbol indicates the date of manufacture (four digits for the year and two digits for the month). Symbols on the mains adapter This symbol indicates that the mains adapter is a class II device. This symbol indicates the compliance with China Compulsory Certication. This symbol indicates that the mains adapter is for indoor use only. This symbol indicates the compliance with USA and Canada safety requirements. This symbol indicates the compliance with Federal Communications Commission requirements. This symbol indicates polarity of d.c. power connector. This CE-mark indicates the compliance with the low voltage and electromagnetic compatibility directive. This symbol indicates to not dispose the device together with unsorted municipal waste (for EU only). The solid bar symbol indicates that mains adapter is put on the market after 13 August 2005. This symbol indicates the compliance with energy efciency requirements. This symbol indicates alternating current. This symbol indicates direct current. 77This symbol indicates the compliance with energy efciency requirements. SGS This symbol indicates that the mains adapter is safety tested. This symbol indicates a short-circuit proof safety isolating transformer. 170053 -12 Singapore Consumer Protection Registration.

This symbol indicates that the electronic device incorporating transformer(s) and electronic circuitry(ies), converts electrical power into single or multiple power outputs. N5586 This symbol indicates the compliance with AUS/NZ requirements N5586 (regulatory compliance mark). TÜV SÜD PSB This symbol indicates the compliance with PSE requirements (Japan, Product Safety Electrical Appliance and Material Safety Law). IP20 This symbol indicates the protection against ingress of solid foreign objects and against harmful effects due to the ingress of water.

883. Important safety information

Failure to follow these instructions/safety information can lead to danger from the device. Subject to technical changes. Separation from the mains is only assured through the disconnection of the mains adapter from the wall socket outlet. Keep the mains adapter away from heated surfaces. Do not reach for any electrical device if it has fallen into water. Unplug immediately. The breast pump should never be left unattended when plugged into a power source. Danger of electrocution! Keep the device dry! Never immerse in water or other liquids! The Swing Flex / Swing Maxi Flex breast pump is not heat-resistant: Keep away from radiators and open ames. Do not expose the motor unit to direct sunlight Never use a damaged device. Replace damaged or worn parts. MAX. 275 h The operating life of the Swing Flex breast pump is 275 hours. Repairs must be performed only by an authorised service agency. Do not repair yourself! No modica- tions to the device are permitted. MAX. 250 h The operating life of the Swing Maxi Flex breast pump is 250 hours. The service life is two years. Device Use the Swing Flex / Swing Maxi Flex breast pump only for its intended use as described in this manual. Do not drive whilst hands-free pumping. Do not use the Swing Flex /Swing Maxi Flex breast pump while bathing or showering. Supervision is necessary when the Swing Flex / Swing Maxi Flex breast pump is used in the vicinity of children. Do not use the Swing Flex / Swing Maxi Flex breast pump while sleeping or overly drowsy. Contact your lactation consultant or breastfeeding specialist if you experience problems or pain. This is a single user product. Use by more than one person may present a health risk. Portable and mobile radio frequency communications equipment can affect the Swing Flex / Swing Maxi Flex breast pump. 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. Use Electrical use

994. Product description Swing Flex

1x Swing Flex tubing article 201.1079 spare part 101034002 1x mains adapter swing on/off button reduce vacuum increase vacuum let-down button LED Spare parts and accessories available for order can be found in chapter 12. Swing Flex – single electric 2-Phase breast pump power adapter port battery compartment PVC tubing port xing clip breast shields: 1 x 21 mm (article 101035239) 1 x 24 mm (article 101035240) 1x motor unit: article 600.0975 spare part 099.0015 article spare part Euro 4.8V 201.1055 099.0016 UK 4.8V 201.1056 099.0017

2x multi lid article 200.2714 2x bottle article 811.0021 2x bottle stand article 101033405 2x membrane 2x lid 11116. Cleaning Washing and sanitising are two different activities. They must be done separately to protect you, your baby and the performance of your breast pump. Wash – To clean the surfaces of the parts by physically removing contamination. Sanitise – To kill living organisms, such as bacteria or viruses, that may be present on the surfaces of the parts.

6.1 Cleaning overview

When to clean Breast shield(s) Connector and membrane Bottles & lids Before 1st use ✔ 6.3 wash ✔ 6.4 sanitise ✔ 6.2 disassemble ✔ 6.3 wash ✔ 6.4 sanitise ✔ 6.2 disassemble ✔ 6.3 wash ✔ 6.4 sanitise After each use ✔ 6.3 wash ✔ 6.3 wash ✔ 6.3 wash Once per day ✔ 6.4 sanitise ✔ 6.4 sanitise ✔ 6.4 sanitise When to clean Tubing Motor unit As needed see chapter 6.5 see chapter 6.6 1212Caution l Do not spray or pour liquid directly onto the pump. l Only use drinking-quality water for cleaning. l Take apart and wash all parts that come in contact with the breast and breast milk immediately after use to avoid drying up of milk residues and to prevent growth of bacteria. l Do not clean the tubing with Quick Clean bags in the microwave. l Unplug the breast pump before cleaning the motor unit.

Note l The pump set requires no mainte- nance. l Take care not to damage parts of the pump set during cleaning. l Do not use the breast milk if bottles or components become damaged. l Remove and dispose the protective cover* from the breast shield before rst use. l Disassemble the pump set into its individual parts (breast shield, connector, membrane, milk bottle). l Open back cap of the connector by squeezing both aps. l Check all parts for damage. l Replace damaged or worn parts.

Before rst use and after each use

Place all parts, except for the tubing, on the top rack or in the cutlery section. Use a commercially available dishwashing detergent. Dry after washing. Use Quick Clean* bags in the microwave in accordance with the instructions. Dry after sanitising.

• Accessories available for order: see chapter 12. For more information, visit www.medela.com. Cover all parts, except the tubing, with water and boil at least for 5minutes. Dry after sanitising. Sink Stovetop Dry with a clean cloth or leave to dry on a clean cloth. Put the clean 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. Drying

1. Rinse all parts with cold, clear

drinking-quality water (approx. 20 °C).

2. Clean these parts with plenty of

warm, soapy water (approx. 30 °C). Use a commercially available washing-up liquid, preferably without articial fragran- ces and colouring (pH neutral).

3. Rinse the parts with cold, clear

drinking-quality water for 10–15seconds (approx. 20 °C). Dry after washing. Dishwasher Microwave

To clean the motor unit, wipe the housing with a clean, damp (not wet) cloth. You may use drinking-quality water and a basic washing-up liquid or a non-abrasive detergent.

Additionally you may use an alcohol-based disinfecting agent. I No visible residues No cleaning needed. l With visible residues

1. Rinse tubing in cool water

2. Wash tubing in warm, soapy water

3. Rinse tubing with clear water

Do not sanitise the tubing.

Note l If the individual components of the pump set are cleaned in a dishwasher, parts may be discoloured by food pigments. This has no impact on the function. l The membrane at the connector prevents the milk from owing into the tubing, however, inspect the tubing after each pumping session for visible residues. If there are visible residues in the tubing, follow the instructions in chapter 6.5.

Plug the mains adapter cord into the motor unit.

7. Preparing for pumping

l You can operate the SwingFlex / Swing Maxi Flex breast pump via battery or mains. l Battery operation: The batteries do not need to be removed when the mains adapter is used for pumping. l Regularly check the condition of the batteries in the motor unit. l If Swing Flex / Swing Maxi Flex will remain unused for a longer period of time, remove the batteries from the battery compartment. l Batteries last for 4 – 6 pumping sessions (approx. 1 ½ hours pumping time).

7.2 Battery operation

Open the battery compartment on the back in the direction of the arrow. l Mains operation: Follow the exact order of the steps. l Only use the mains adapter supplied with the Swing Flex / Swing Maxi Flex. l Make sure the voltage of the mains adapter is compatible with the power source. Info Warning

Plug the mains adapter into the mains socket. The motor unit is now ready for operation. Insert four AA Mignon LR6 batteries for Swing Flex . Insert six AAA Micro 1.5 V batteries for Swing Maxi Flex. Close the battery compartment. The pump is ready for operation via battery.

Check pump set components for wear or damage before use and replace if necessary. Make sure parts are cleaned according to chapter 6 before assembling the pump set. Carefully place the membrane into the connector with the ap into the opening of the connector. Make sure that the membrane forms a seal around the edge of the connector.

7. Preparing for pumping

l Wash hands thoroughly (at least one minute) with soap and water before touching the breast and pump parts. Dry your hands with a fresh towel or a single-use paper towel. l Also, bottles and component parts may become damaged if mishandled, e.g. dropped, over-tightened, or knocked over. l Take appropriate care in handling bottles and componets.

7.3 Assembling the pump set

l Carry out all the steps with care and assemble the pump set correctly. Otherwise a good vacuum may not be achieved. l Use Medela original accessories only. l Hold the tubing by the connecting piece while attaching and detaching it. l All components must be completely dry before use. Caution Info Note Screw bottle into connector.

“CLICK ” Close the lid of the connector until it audibly clicks. Insert the tubing into the corresponding opening in the lid of the connector. Insert the other end of the tubing into the motor unit. Insert the breast shield onto the connector. 19198. Expression l Step 2 (chapters 8.1, 8.2, 8.3): l The product comes with two different breast shield sizes 21 mm and 24 m m . l Answer the following questions to nd out whether the available breast shield sizes t: l Does your nipple rub the tunnel sides to the point of causing discomfort? l Do you see excessive areola being pulled into the tunnel? l Do you see any redness? l Is your nipple or areola turning white? l Do you feel unexpressed milk after breast milk pumping? If you answered “YES” to any of these questions, consider trying a new size by following the measuring instruc- tions at www.medela.com. If you are still unsure that you selected the right breast shield size, contact your lactation consultant or breast- feeding specialist. See brochure “Choosing your Medela breast shield size”. Caution

l Step 3 (chapters 8.1, 8.2, 8.3): Do not hold the pump set by the bottle. This can lead to blockage of the milk ducts and engorgement. Note

8.2 Swing Maxi Flex –

Preparing for single pumping

Insert the unused short tubing into the tubing holder.

Preparing for single pumping

The oval breast shield can be rotated (360°) and placed in the desired position to have the most comfortable t for you. 2020For more information on pumping, see

Place the breast shield on your breast so that your nipple is properly centred in the tunnel. Hold the breast shield onto your breast with your thumb and index nger. Support your breast with the palm of your hand.

Hold the breast shield onto your breast with your thumb and index nger. Support your breast with the palm of your hand. Place the breast shield of one bottle on the rst breast so that the nipple is prop erly centred in the tunnel. For more information on pumping, see

2121l Step 2 (chapter 8.3): l Wash hands thoroughly (at least one minute) with soap and water before touching the breast, the clean pump parts and clean pump set. Dry your hands with a fresh towel or a single-use paper towel. l Do not hold the pump set by the bottle. This can lead to blockage of the milk ducts and engorgement. Caution

Switch on the breast pump with

Preparing for double pumping

The oval breast shield can be rotated (360°) and placed in the desired position to have the most comfortable t for you.

l Double pumping saves time and increases the energy content of the milk. Info

Place the breast shield on your breast so that your nipple is properly centred in the tunnel. Hold the breast shield onto your breast with your thumb and index nger. Support your breast with the palm of your hand.

Place the second breast shield on your breast so that your nipple is properly centred in the tunnel. For more information on pumping, see

23238.4 Swing Maxi Flex – Preparing for hands-free expression with the Easy Expression Bustier

l Easy Expression Bustier must be purchased seperately. More information on www.medela.com

Put on the Easy Expression Bustier and close it using the hook on top. Connect the assembled pump set to the breast shields. 2424For more information on pumping, see

Leave the zip open slightly.

Place the breast shield on your breast under the bustier such that your nipple is centred in the tunnel of the breast shield. Start pumping. 2525i

l Always disconnect the Swing Flex / Swing Maxi Flex from the power source after expression. l Only ll the bottle to the 150 ml mark. l Contact your your lactation consultant or breastfeeding specialist if you can express only minimal or no milk, or if expression is painful. l Swing Flex / Swing Maxi Flex switches off automatically if it has been running for 30 minutes with no interaction. l Do not kink the tubing during expression. Lights up OnDoes not light up OffEven, regular ashing Stimulation phaseLight constantly on Expression phaseRapid ashing Min./Max. vacuum Note Caution Info The following table shows the different LED status: Switch off the breast pump with

Switch on the breast pump with

➙ The stimulation phase lasts a maximum of two minutes. The stimulation phase will then automatically change to the expression phase.

Use the bottle stand to prevent the bottle from tipping over. Close the bottle with a lid. ➙ Follow the instructions in chapter 9 “Storing and thawing breast milk”. Clean in accordance with chapter 6.

The Max. Comfort vacuum can be adjusted in every phase. Max. Comfort vacuum: Use to increase the vacuum until it is slightly uncomfortable. Press to reduce the vacuum, until it is comfortable again. If your milk starts to ow earlier, press the button to change to the expression phase. ➙ Make sure that the milk is owing into the bottle properly. 27279. Storing and thawing breast milk

Storage guidelines for freshly expressed breast milk (for healthy term babies) Room temperature 16 to 25 °C (60 to 77 °F) Refrigerator 4 °C (39 °F) or colder Freezer –18 °C (0 °F ) or colder Breast milk thawed in the refrigerator Up to 4 hours is best *Up to 6 hours for milk expressed under very clean conditions Up to 3 days is best *Up to 5 days for milk expressed under very clean conditions Up to 6 months is best *Up to 9 months for milk expressed under very clean conditions At room temperature: Up to 2hours 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 sanitiser. The pump parts, bottles and pumping area must be clean. Breasts and nipples do not need to be washed before pumping. l These guidelines for storage and thawing of breast milk are a recommendation. Contact your lactation consultant or breastfeeding specialist for further information. l Store breast milk in the coldest spot of the refrigerator (at the back of the glass shelf above the vegetable compartment). l Freeze expressed breast milk in plastic bottles or milk storage bags. Do not ll the bottles or bags more than full to allow space for possible expansion. l Label the bottles or bags with the date and volume of expression. l Plastic bottles and component parts become brittle when frozen and may break when dropped. l Do not use the breast milk if bottles or components become damaged.

Do not thaw or warm breast milk in a microwave or a pan of boiling water. This helps preserve important components and prevents burns. l To preserve breast milk components, thaw the milk overnight in the refrigerator. Alternatively, hold the bottle or bag under warm water (max. 37 °C / 98.6 °F). l Gently swirl the bottle or bag to mix any fat that has separated. Avoid shaking or stirring the milk.

Caution 28282810. Troubleshooting Problem Solution If the motor is not running Check presence of mains current. Check the position of the batteries in the battery compartment. If there is low or no suction Verify the membrane is clean and not damaged. Ensure the membrane is attached correctly to the connector. Check all connections. Check the ends of the tubing t securely into the back of the connector and into the port on the breast pump. Do not kink the tubing during expression. Ensure the breast shield forms a complete seal around the breast. If condensation appears in the tubing Clean the tubing as described in chapter 7.5. Shake out any water drops. The pump becomes wet Unplug the mains adapter from the socket. Switch off the pump. Do not place the pump upside down. Control panel must point upwards. Store the pump in a dry, warm place for 24 hours. Note: Do not expose the pump to direct sunlight. Do not accelerate the drying process by use of heat. 2929Warranty The “International Warranty” brochure contains detailed warranty information. Disposal This is a single user product. Use by more than one person may present a health risk. The unit is made of metals and plastics and should be disposed of in accordance with the European directives 2011/65/EU and 2012/19/EU. Additional, local guidelines must also be observed. Please take care that you dispose of the unit and its accessories in accordance with your local disposal guidelines.

11. Warranty / Disposal

12. Spare parts and Accessories

150 ml breast milk bottles (3 pcs) 250 ml breast milk bottles (2 pcs) 008.0040 * Quick clean Other Medela products are available at www.medela.com

12. Spare parts and Accessories

Article number Product

Swing Maxi Flex adapter (100-240V; 12V) Euro Swing Maxi Flex adapter (100-240V; 12V) UK Swing Maxi Flex adapter (100-240V; 12V) US / JP Swing Maxi Flex adapter (100-240V; 12V) AUS / NZ Swing Maxi Flex adapter (100-240V; 12V) CN 099.0270 Swing Maxi Flex motor unit 101034003 Swing Maxi Flex tubing 101034005 connector Spare parts Swing Maxi Flex 3232Swing Flex and Swing Maxi Flex are 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.

13. EMC / Technical description

Warning – The electric breast pumps Swing Flex and Swing Maxi Flex should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the electric breast pumps Swing Flex and Swing Maxi Flex should be observed to verify normal operation in the conguration 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 can affect the electric breast pumps Swing Flex and Swing Maxi Flex and should be kept at least a distance 30 cm away from the equipment.