Mini Electric - Breast pump MEDELA - Free user manual and instructions

USER MANUAL Mini Electric MEDELA

134–1591. Intended use / Population – Contraindication 5

2. Meaning of symbols 6

5.1 Before using for the rst time and after every use 12

5.2 Before using for the rst time and once a day

6. Preparing for pumping 16

6.1 Mains operation 16

6.2 Battery operation

6.3 Assembling the pump set

7.1 Preparing for pumping 20

8. Storing and thawing breast milk 24

9. Feeding breast milk 25

12. Complete care during breastfeeding time 28

Table of Contents 44The 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 Mini Electric 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.This symbol indicates the date of manufacture (four digits for the year and two digits for the month). 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.

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 the manufacturer. This symbol indicates do not dispose the device together with unsorted municipal waste (for EU only). This symbol indicates a type BF applied part.

- This symbol indicates the positioning of battery cell. IP22 This symbol indicates the protection against ingress of solid foreign objects and against harmful effects due to the ingress of water. 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 safety tested. This symbol indicates that the mains adapter is for indoor use only. This symbol indicates the compliance with Canada safety requirements. This symbol indicates the compliance with USA and Canada safety requirements. This symbol indicates the compliance with USA safety requirements. 125°C This symbol indicates the mains adapter is tted with thermal cut-out (number indicates cut-out temperature) This symbol indicates polarity of d.c. power connector. This symbol indicates isolating safety transformer. 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 Japanese safety requirements. This symbol indicates alternating current. This symbol indicates direct current. This symbol indicates the compliance with the essential requirements of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. 9 VDC

773. Important safety information

Failure to follow these instructions/safety information can lead to danger from the device. Subject to technical changes. Device Danger of electrocution! Keep the device dry! Never immerse in water or other liquids! The Mini Electric breast pump is not heat-resistant: keep away from radiators and open ames. Do not expose the motor unit to direct sunlight. Repairs must be performed only by an authorised service agency Do not repair yourself! No modications to the device are permitted. Never use a damaged device. Replace damaged or worn parts. MAX. 150 h The operating life of the Mini Electric breast pump is 150 hours. The service life is two years. Electrical use 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. 88Use Use the Mini Electric breast pump only for its intended use as described in this manual. 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. Do not use the Mini Electric breast pump while bathing or showering. Do not use the Mini Electric breast pump while sleeping or overly drowsy. This is a single user product. Use by more than one person may present a health risk. Do not drive whilst hands-free pumping. Supervision is necessary when the Mini Electric breast pump is used in the vicinity of children. Contact your lactation consultant or physician if you experience problems or pain. Portable and mobile radio frequency communications equipment can affect the Mini Electric breast pump. Important: l Plastic bottles and component parts become brittle when frozen and may break when dropped. 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 components. l Do not use the breast milk if bottles or components become damaged. 991x PersonalFit breast shield M (24 mm) (for other breast shield sizes see Chapter 12, page 28) 1x PersonalFit connector 1x bottle 1x bottle stand

time and after every use Disassemble the pump set into individual parts.Rinse all parts with cold, clear water (approx. 20 °C) for 10–15 seconds. l The pump set requires no main-tenance.l Take care not to damage parts of the pump set during cleaning.l If the individual components of the pump set are cleaned in a dish-washer parts may be discoloured by food pigments. This has no impact on the function. Note

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 dry up of milk residues and to prevent growth of bacteria.Caution

Rinse all parts with cold, clear water (approx. 20 °C). If you clean the individual parts of the pump set in the dish- washer, place them on the top rack or in the cutlery section. Clean all parts with plenty of warm soapy water (approx. 30 °C). Dry with a clean cloth or leave to dry on a clean cloth. As an alternative to steps 2, 3 and 4.

the rst time and once a day Disassemble the pump set into individual parts.Dry with a clean cloth or leave to dry on a clean cloth.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 dry up of milk residues and to prevent growth of bacteria.l When boiling, a tea spoon of citric acid may be added to avoid a build-up of limescale.l Store the pump set in a clean bag/container until next use. Or store it in clean paper or a cloth.Caution Note

Cover all parts with water and boil for ve minutes. Use Quick Clean* microwave bags in accordance with the instructions.

*More information at www.medela.com Wipe off with a clean, damp cloth.

Plug the mains adapter cord into the motor unit.

6. Preparing for pumping

l re 6.2 Battery operation: The batteries do not need to be removed when the main adapter is used for pumping.I Regularly check the condition of the batteries in the motor unit. I If Mini Electric will remain unused for a longer period of time, remove the batteries from the battery compartment.

6.2 Battery operation

Remove the battery compartment cover.l re 6.1 Mains operation: Follow the exact order of the steps.l Only use the mains adapter supplied with the Mini Electric.l Make sure the voltage of the mains adapter is compatible with the power source. Info Warning

6.2 Battery operation

Plug the mains adapter into the mains socket. Insert two AA LR6 batteries. Slide the cover back.

Carefully push the valve membrane onto the valve head until it engages.

6. Preparing for pumping

l Wash hands thoroughly (at least one minute) with soap and water before touching the breast and pump parts. Screw the bottle onto the breast shield.

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 Check pump set components for wear or damage before use and replace if necessary.l All components must be completely dry before use.Caution Info Note

Push the breast shield onto the connector. Insert the motor unit into the connector. Rotate motor unit clockwise until the long battery compart- ment is located over the bottle. Push the valve head and mem- brane onto the connector. Position valve head laterally.

Place the breast shield on your breast so that your nipple is properly centred in the tunnel.

pumping Set the vacuum control to minimum.

l re step 2 (chapter 7.1): Answer the following questions to nd out whether the available breast shield size will t:l Is your nipple moving freely in the tunnel? l Is minimal or no areolar tissue being pulled into the tunnel of the breast shield? l Do you see a gentle, rhythmical motion in the breast with each cycle of the pump? l Do you feel the breast emptying all over? l Is your nipple pain-free? If the answer to any of these ques-tions is “No” or if you experience problems or pain during expression, consult your breastfeeding and lactation consultant or midwife.Caution l re step 2 (chapter 7.1): Do not hold the pump set by the bottle. This can lead to blockage of the milk ducts and engorgement.l Wipe the breast with a warm washcloth (do not use alcohol). Note

Hold the breast shield onto your breast with your thumb and index nger. Support your breast with the palm of your hand. Turn the vacuum control up towards MAX until it is slightly uncomfortable. Then turn down slightly towards MIN. Make sure that the milk ows into the bottle properly. Switch on the breast pump. Slide the switch to Start. 2121i

Turn off breast pump. Slide switch to Stop. l Always disconnect the Mini Electric from the mains after expression. l Only ll the bottle to the 150 ml mark. l Contact your midwife or lactation consultant if you can express only minimal or no milk or if expression is painful. Note Caution

Use the stand to prevent the bottle from tipping over. Close the bottle with a lid. Follow the instructions in

Chapter 8 “Storing and thawing

breast milk”. Clean in accordance with chapter 5, page 12. 23238. Storing and thawing breast milk

Storage guidelines for freshly expressed breast milk (for healthy terms babies) Room temperature Refrigerator Freezer Thawed breast milk 4–6 hours at 19 to 26 °C ( 66 to 78 °F) 3–8 days at 4°C (39 °F) or lower 6–12 months –18 to –20 °C (0 to - 4 ° F) In refrigerator for 10 h max. Do not refreeze! l Do not store breast milk in the door of the refrigerator. Instead choose the coldest part of the refrigerator (this is at the back of the glass shelf above the vegetable compartment).

l You can freeze expressed breast milk in milk bottles or “Pump & Save”* bags. Do not ll the bottles or bags more than 3/4 full to allow space for possible expansion. l Label the bottles or “Pump & Save” bags with the date of expression.

Do not thaw frozen breast milk or do not warm breast milk in a microwave or a pan of boiling water to avoid loss of vitamins, minerals and other important components and to prevent burns. l ln order to preserve the components of the breast milk, thaw the milk in the refrigerator overnight. Alternatively, you can hold the bottle or “Pump & Save” bag under warm water (max. 37 °C). l Gently swirl the bottle or “Pump & Save” bag to mix any fat that has separated. Avoid shaking or stirring the milk. Warning 2424Medela recommends Calma for feeding breast milk. With Calma l your baby can feed, pause and breathe regularly. l milk will ow when a vacuum is created. l your baby’s natural feeding behaviour will be maintained, supporting easy transition back to the breast. Info

Calma – unique feeding solution for breast milk. You can nd detailed information about Calma on the Medela website (www.medela.com).

9. Feeding breast milk

252510. Troubleshooting Problem Solution If the motor is not running Check presence of mains current. Check that the device is switched on. If there is loss of power during battery operation Replace batteries. If there is low or no suction Ensure the breast shield forms a complete seal around the breast. All the connections are secure. The valve membrane is lying at against the valve head. Check that the valve membrane and valve head are clean and undamaged. Motor must be properly secured to the connector. All components must be completely dry. 2626Warranty The “International Warranty” brochure contains detailed warranty information. Disposal The unit is made of various metal and plastics. Before disposal, the device is to be rendered unusable and it must not be disposed of as unsorted municipal waste in accordance with local regulations. Use your local return and collection system for waste electrical and electronic equipment (incl. batteries). Improper disposal may have harmful effects on the environment and on public health.

Breast milk bottle 150 ml (3 pcs) Breast milk bottle 250 ml (2 pcs)

Cooling Bag CityStyle breast pump Bag Other Medela products are available on the www.medela.com web site. The following accessories for the Mini Electric are available from Medela distribution partners by specifying the product number.

12. Complete care during breastfeeding time

• If the result of expression is unsatisfactory or expression is painful, contact your midwife or lactation consultant. A different size of PersonalFit breast shield may help make expression more comfortable and successful. 2828Breast care Evidence based research Feeding Breast milk management Collecting Pumping 29291. Verwendungszweck/Zielgruppe – Kontraindikationen 31

Electromagnetic emissions The electric breast pump Mini Electric is intended for use in the electromagnetic environment specied below. The customer or the user of the electric breast pump Mini Electric should assure that it is used in such an environment. Emission tests Compliance Electromagnetic environment – guidance RF emissions CISPR 11 Group 1 The electric breast pump Mini Electric 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 CISPR 11 Class B The electric breast pump Mini Electric 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. Harmonic emissions

Class A Voltage uctuations / icker emissions

Warning – The electric breast pump Mini Electric should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the electric breast pump Mini Electric should be observed to verify normal operation in the conguration in which it will be used.

No signicant voltage changes 160Electromagnetic immunity The electric breast pump Mini Electric is intended for use in the electromagnetic environment specied below. The customer or the user of the electric breast pump Mini Electric should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance Electrostatic discharge ( ESD )

± 6 kV contact ± 8 kV air ± 6 kV contact ± 8 kV air Floors should be wood, concrete or ceramic tile. If oors are covered with synthetic material, the relative humidity should be at least 30%. Electrical fast transient / burst

± 2 kV for power supply lines ± 1 kV for input / output lines ± 2 kV for power supply lines Not applicable

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

± 1 kV line( s ) to line(s) ± 2 kV line( s ) to earth ± 1 kV differential mode Not applicable

Mains power quality should be that of a typical commercial or hospital environment. Electromagnetic Compatibility (EMC, IEC 60601-1-2:2007, Table 2)

No earth, class II equipment 161Voltage dips, short interruptions and voltage variations on power supply input lines

for 5 s Mains power qual- ity should be that of a typical commercial or hospital environment. If the user of the electric breast pump Mini Elec- tric requires continued operation during power mains interruptions, it is recommended that the electric breast pump Mini Electric is powered from an uninterruptible power supply or a bat- tery. Power frequency (50/60 Hz) magnetic eld

3 A/m 3 A/m Power frequency mag- netic elds should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE U

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

13. EMC / Technical description

162Electromagnetic immunity The electric breast pump Mini Electric is intended for use in the electromagnetic environment specied below. The customer or the user of the electric breast pump Mini Electric should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance Conducted RF

3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2,5 GHz 3 Vrms 3 V/m Portable and mobile RF communi- cations equipment should be used no closer to any part of the electric breast pump Mini Electric, including cables, than the recommended separation distance calculated from the equation applicable to the fre- quency of the transmitter. Recommended separation distance d = 1.2√P d = 1,2√P 80 MHz to 800 MHz d = 2,3√P 800 MHz to 2,5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufac- turer and d is the recommended sepa- ration distance in metres (m). Field strengths from xed RF trans- mitters, as determined by an electro- magnetic site survey,

should be less than the compliance level in each fre- quency range.

Interference may occur in the vicinity of equipment marked with the follow- ing symbol: Electromagnetic Compatibility (EMC, IEC 60601-1-2:2007, Table 4) 163a Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) tel- ephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the electric breast pump Mini Electric is used exceeds the applicable RF compliance level above, the electric breast pump Mini Electric should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the electric breast pump Mini Electric.

Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m. Note 1 At 80 MHz and 800 MHz, the higher frequency range applies. Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection from structures, objects and people.

13. EMC / Technical description

164Recommended separation distances between portable and mobile RF communications equipment and the electric breast pump Mini Electric The electric breast pump Mini Electric is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the electric breast pump Mini Electric can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the electric breast pump Mini Electric as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W Separation distance according to frequency of transmitter M 150 kHz to 80 MHz d = 1,2√P 80 MHz to 800 MHz d = 1,2√P 800 MHz to 2.5 GHz d = 2,3√P 0,01 0.12 0.12 0.23 0,1 0.37 0.37 0.74