LACTINA Instructions for Use Sept 2012

EN

Instructions for use

4

DE

Gebrauchsanweisung

18

FR

Mode d’emploi

32

IT

Istruzioni per l’uso

46

NL

Gebruiksaanwijzing

60

EMC

74

3

Lactina™ Breastpump

l

Mother’s milk is the best nutrition for babies. Lactina gives you and your baby optimal support during the breastfeeding period. The attractive breastpump for hospitals and home rental is especially suitable for long-term and frequent pumping and encourages milk production in the long term, too.

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Indications For Use

The Lactina Breastpump is a powered breastpump: • To be used by lactating women to express and collect milk from their breast. • To initiate and maintain a milk supply as well as collect breastmilk at work or during other absences from the baby. • To initiate and maintain a milk supply if direct breastfeeding is not possible. • To relieve engorgement. • For use in hospitals or home rental.

lII

Important Safeguards

When using electrical devices, basic safety precautions should always be followed, including the following: Read all instructions before use. • • • • • •

• • • • • • • •

4

Use the product only for its intended use as described in this instruction manual. Only use the power cord that comes with the Lactina Breastpump. Make sure the voltage of the device is compatible with the power source. Always unplug electrical devices immediately after using. The product should never be left unattended when plugged into a power source. Separation from the mains is only assured through the disconnection of the power cord from the wall socket outlet. Keep the power cord away from heated surfaces. Never operate an electrical device if it has a damaged power cord or plug, if it is not working properly, if it has been dropped or damaged, or dropped into water. Do not use outdoors. Keep appliance dry and do not place in direct sunlight. Do not get the product wet. Do not use while bathing or showering. Do not place in or drop pump unit into water or other liquid. Do not spray or pour liquid directly onto the pump.

EN

• • • • •

Do not store or use this product where it can fall or be pulled into a tub or sink. Do not reach for any electrical device if it has fallen into water. Unplug immediately. Use Medela original accessories only. Check pump kit components for wear or damage. The pump kit is a personal care item and is not to be shared between mothers without proper sterilization to prevent the risk of cross-contamination. Pump only with the motor in an upright position. Do not use while sleeping or overly drowsy. Supervision is necessary when this product is used in the vicinity of children. If problems or pain occur, consult your lactation consultant or physician. Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. Portable and mobile radio frequency communications equipment can affect the Lactina Breastpump. The Lactina Breastpump needs special precautions regarding EMC (Electromagnetic compatibility) and needs to be installed and put into service according to the EMC information provided in these instructions for use. There are no user-serviceable parts inside the Lactina. Do not attempt to repair the Lactina Breastpump yourself.

• • • • • • • •

SAVE THIS INSTRUCTION MANUAL

lV

Assembly Instructions

1

Snap membrane onto valve until membrane lies completely flat.

b

+ c

2

Push assembled valve and membrane onto breastshield. Ensure sidewise position of valve as indicated on picture.

+ a1 a2

b c EN

5

lV

Assembly Instructions

3

Screw bottle into breastshield.

+ a b c

d

4

Insert adapter end of tubing into opening in breastshield.

a b c d

+ f

5

Slip rubber seal onto piston until it snaps into place - the larger side faces the handle. To ensure proper seal, hold rubber seal firmly and twist piston.

+ h

i

6

Slide vacuum regulator ring onto cylinder.

➜ g

6

EN

j

7

Slide piston into cylinder.

➜ j

g

i

8

h

Snap port cap onto cylinder holder.

+ l

k

9

Screw piston/cylinder assembly tightly into cylinder holder.

+ k

10

l

g h i

j

Insert plug at the back side of the cylinder holder into the hole on the front side of the Lactina. Rotate until tab of cylinder holder is securely placed in slit of Lactina.

EN

7

lV

Assembly Instructions

11

Push piston into rubber clamp of Lactina pumping arm until it snaps in.

12

Push adapter end of tubing into opening on cylinder holder. If single pumping, insert port cap into the unused opening of cylinder holder.

13

V

If double pumping, insert port cap into the hole in the middle of cylinder holder.

Electrical Operation

Plug the power cord into a standard electrical outlet.

8

EN

VI

Pumping

Be comfortably seated and relax. Use a footrest, when pumping or when feeding your baby. Elevating your feet puts you into proper sitting position to avoid stress on the lower back and perineum.

1

Center your breastshield over your nipple. • •

2

Do not tilt or overfill bottles when pumping. Take care not to kink tubing while pumping.

Set the vacuum regulator to minimum and switch on the breastpump. On Off

3

Adjust the vacuum to your Maximum Comfort Vacuum™. This is the highest vacuum you can use and still feel comfortable (different for every mother). To find your Maximum Comfort Vacuum increase vacuum until pumping feels slightly uncomfortable (not painful), then decrease slightly. Research has shown that you will pump more efficiently - meaning get more milk in less time - when pumping at Maximum Comfort Vacuum™. Once finished pumping, switch off the breastpump, unplug it, and disassemble the pump kit items. Close the bottle and store it for later use. Use bottle stand to prevent tip over.

EN

9

VI

Pumping

Lactina Select only The Lactina Select features an additional knob to adjust the pumping speed. Choose a fast pumping rhythm to start your milk flowing (setting 7 corresponds to highest speed level). Once your milk starts to flow or you sense milk ejection you may adjust the rhythm by decreasing speed slightly (e.g. setting 4).

VII Breastshield Fitting Choosing the right size of Breastshield A correctly fitted breastshield avoids compression of any milk ducts during pumping to ensure optimal breast emptying and maximum milk output. Your breastshield is the right size if your answer to the following questions is «Yes»: • Is your nipple moving freely in the tunnel? • Is minimal or no areolar tissue being pulled into the tunnel of the breastshield? • Do you see a gentle, rhythmical motion in the breast with each cycle of the pump? • Do you feel the breast emptying all over? • Is your nipple pain-free? If your answer to any of the above questions is «No», try a larger (or smaller) breastshield. Medela PersonalFitTM Breastshield: Available in five sizes - because one size does not fit all.

10

EN

VIlI Manual Pumping Follow steps 1–7 (excluding step 4) on page 3/4/5

8

Screw cylinder into breastshield.

+ a b c d

9

IX

g h i

j

Set the vacuum regulator to minimum and start pumping. Adjust the vacuum to your Maximum Comfort Vacuum™. This is the highest vacuum you can use and still feel comfortable (different for every mother). To find your Maximum Comfort Vacuum increase vacuum until pumping feels slightly uncomfortable (not painful), then decrease slightly.

Cleaning and Hygiene Important

• • •

 se drinking water quality for any of the following described U cleaning procedures. Clean parts immediately after use to avoid dry up of milk residues and to prevent from growth of bacteria. Disassemble all parts prior to cleaning. Especially be sure to remove the yellow valve head from the breastshield and separate the white valve membrane from the valve head.

EN

11

Cleaning and Hygiene

IX

Cleaning at home

Follow these cleaning instructions unless you are told otherwise by your healthcare professional. Prior to first use and once daily • Disassemble, wash and rinse all parts of your pump kit that come in contact with the breast and milk (a+b+c+d+m+n+o). • Place parts in a saucepan of sufficient capacity. • Fill with cold water until the parts are well covered. Optionally, a tea spoon of citric acid may be added to avoid a build-up of limescale. • Heat it up and allow to boil for 5 minutes. • Remove from stove and drain water off. • Dry parts with a clean towel. Alternatively, the disassembled parts can be sanitized in top rack of dishwasher, with the Medela Quick Clean microwave bags or with the B-Well steam sterilizer. Note: Food colorings may discolor components which will not affect performance. After each use • Disassemble and handwash all parts of your pump kit that come in contact with the breast and milk (a+b+c+d+m+n+o) in warm, soapy water. • Rinse in clear water.  • Dry parts with a clean towel.

Cleaning in hospitals

The following cleaning instructions are general recommendations and may individually be adjusted based on the hospital’s specific directives and cleaning practices. Important It is recommended to provide each mother an own personal pump set and to clean, disinfect and sterilize (e.g. autoclave) all components after each use or, latest each time they are handed over to the next mother. Use by more than one mother without adequate sterilization may pose a health risk (e.g. risk of cross-contamination) and voids the warranty.

12

EN

Cleaning Disassemble and thoroughly wash all parts in warm, soapy water. Rinse in clear water. Disinfecting Disinfect all parts by washing in a thermic washing machine (at approx. 93° C). Sterilizing Prior sterilizing visually check parts if clean and intact. Sterilize all parts by autoclaving at 134° C for 3 (or 18) minutes or at 125° C for 15 – 20 minutes. Do not stack parts or apply external pressure to avoid damages. Alternatively, the parts can be EO-sterilized (Ethylene Oxide). Tubing care

Hints

Hygiene

Inspect the tubing after each pumping session for condensation and/or milk. If condensation appears in the tubing Let the pump run after you have completed pumping with tubing attached for 1– 2 minutes or until dry. If milk gets into the tubing If milk accidentally gets into the tubing turn off the pump and unplug from power source. Remove and clean the tubing according to the instructions «Prior to first use and once daily». Shake water droplets out and hang to air-dry. For faster drying, attach the tubing to pump and run for 1– 2 minutes or until dry. After cleaning, when parts are not in use, put in a clean zip lock bag or store in a container with lid. Alternatively, the parts can be wrapped in a clean paper or cloth towel. • • • •

 ash hands thoroughly with soap and water before touching W the breast and pump parts. Avoid touching the inside of bottles and lids. Clean the breast and surrounding area with a damp cloth. Do not use soap or alcohol which can dry the skin and cause cracked nipples.

EN

13

IX

Cleaning and Hygiene

Breastpump care

Unplug breastpump prior to cleaning At home In hospitals

• • •

X

Daily or when spills occur Immediately when spills occur In between each mother and/or on a regular basis, e.g. daily

 se a damp (not wet) cloth to wipe over the breastpump. U Optionally, soapy water or a non-abrasive detergent may be used. Do not spray or pour liquid directly onto the pump. Do not immerse the pump unit in water.

Storing / Thawing Breastmilk

Check with your hospital for specific instructions. Breastmilk Storage (For Healthy Term Babies)

Freshly expressed breastmilk Thawed breastmilk (previously frozen)

• • • •

Room Temperature Do not leave at room temperature Do not store

Refrigerator

Refrigerator Freezer Compartment

3 – 5 days at approx. 4° C

6 months at 12 months at approx. -16° C approx. -18° C

10 hours

Deep Freezer

Never refreeze

When freezing do not fill bottles/bags more than 3/4 full to allow space for expansion. Label bottles/bags with the date of pumping. Do not store breastmilk in the door of the refrigerator. In order to preserve the components of the breastmilk, thaw in the refrigerator overnight or by holding the bottle/bag under running warm water (max. 37° C). • Gently shake the bottle/bag to blend any fat that has separated. • Do not thaw frozen breastmilk in a microwave oven or in a pan of boiling water (danger of burning).

14

EN

XI

Troubleshooting

If the motor is not running

Check • mains power is present • the device is switched on

If there is low or no suction

Make sure • the breastshield forms a complete seal around the breast. • all connections of the kit and breastpump are secure. • the white valve membrane is laying flat against the yellow valve head. Check that the valve head and membrane are clean and not damaged. See «Assembly Instructions». • the ends of the tubing are fit securely into the back of the breastshield and into the opening on cylinder holder. • the rubber seal is correctly attached onto piston. • the piston/cylinder is correctly attached onto cylinder holder or breastshield. • the cylinder holder including piston/cylinder is assembled properly onto the Lactina. • If single pumping, make sure the port cap is inserted into the unused opening of cylinder holder. Take care not to kink or pinch tubing.

If there is an overflow

If milk accidentally gets into the tubing • Turn off the pump and unplug from power source. • Use a damp (not wet) cloth to wipe the pump. • Refer to cleaning instructions «Tubing care and Breastpump care». • If necessary clean the pump kit. • When components are completely dry, reassemble breastpump and kit.

EN

15

XII Warranty 3-year warranty for the unit from the date of purchase, excluding pump set and accessories. The manufacturer is not liable for any damage or consequential damage caused by incorrect operation, inappropriate usage or use by unauthorized persons. Routine checks and servicing may only be carried out by Medela authorized personnel.

XIII 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. Improper disposal may have harmful effects in the environment and on public health.

16

EN

XIV Parts List

a1 a2 b c d e f g h i j k l m n o

Article numbers

Breastshield (24 mm)

810.7084

Connector

810.7088

Valve head

810.0475

Valve membrane

820.7013

Bottle (150 ml)

811.0020

Bottle stand

810.0462

Silicone tubing (105 cm)

800.0828

Cylinder

810.0717

Piston

810.0494

Rubber seal

200.2575

Vacuum regulator ring

200.2775

Cylinder holder

810.0668

Port cap

820.0135

Cap

810.0474

Lid

810.7062

Disc

810.0473

Accessories (sold separately) • One-Day Pump Set for a limited number of uses (max. 24 hours or 8 pumping sessions) • Disposable bottles (80 ml /150 ml) for one-time use only • Car adapter

800.0830/200.0235 800.0835/200.1153 928.7001

Does not contain Bisphenol-A, DEHP (Phthalate) or Latex. Subject to change. Content may vary from picture.

EN

17

EMC / Technical Description Electromagnetic Compatibility (EMC, IEC 60601-1-2:2001) IEC 60601-1-2, Table 201

Electromagnetic Emissions The Lactina breastpump is intended for use in the electromagnetic environment specified below. The customer or the user of the Lactina breastpump should assure that it is used in such environment.

Emission Tests

Compliance

RF emissions CISPR 11

Group 1

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations / flicker emissions IEC 60000-3-3

Complies

Electromagnetic environment - guidance The Lactina breastpump 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.

The Lactina breastpump 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.

Warning – The use of accessories and cables other than those specified may result in increased emissions or decreased immunity of the Lactina breastpump. The Lactina breastpump should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Lactina breastpump should be observed to verify normal operation in the configuration in which it will be used. The Lactina breastpump was found to have no essential performance by a risk analysis and thus, was not tested for immunity to electromagnetic disturbances (IEC60601-1-2:2001, 6.8.3.201 i)

74

EN DE FR IT NL

Technical specifications Technische Daten Caractéristiques techniques vacuum (approx.) Caratteristiche tecniche -50 … -250 mmHg Technische gegevens -7 … -33 kPa 54 … 120 cpm 100 – 240 V 50vacuum / 60 Hz(approx.) 0.5 A ... -240 mmHg -100

-13.33 ... -32 kPa Lactina Electric Plus 50 cpm Lactina Select 40 – 60 cpm

+40 +5 °C

+50

°C

12 V DC 25 W T 2.5 A

Operation Betrieb En Service Utilizzo Gebruikt

95

Transport / Storage Transport / Lagerung Transport / Stockage Transport / Stoccaggio Transport / Opslag

20

T 800 mA / 5 x 20 / 250V

100 -240 V 50 / 60 Hz 50 VA alternating current

80 -20

80

20

20

Medela Art. Nr.

95

106

20

T 1.25 A / 6.3 x 32 / 250 V

70

kPa

Type 600.0837 / 600.0838 Medela only Art. Nr. 928.7001

Car adapter / Autoadapterkabel Câble de branchement sur 2 x 6 V, 1.2 Ah allume-cigares / Adattatore per 12 V DC automobile / Auto-adapter

Type 16 Yuasa NP 1.2-6

T 1.25 A direct current

900

410

410 mm

180

250

150 mm

106

kg kg

2.9 2.4kg kg +40

+5 °C

+50 -20 °C

Protection class II Type B

Protection class TypeFDA B (GMP) S

AS

3.5 kg

S

AS

70 CL

kPa

CL

70

ISO 9001 ISO 13485 CE (93/42/EEC)

FDA (GMP) ISOPlease 9001see accompanying papers / Begleitpapiere beachten / Respecter les ISOconsignes 13485 des documents d’accompagnement / Consultare la documentazione allegata / CE (93/42/EEC) Zie bijgevoegde documenten

Operation Betrieb En Service Utilizzo Gebruik

Must not be disposed of together with household refuse / Darf nicht zusammen mit Hausmüll entsorgt werden / Ne doit pas être éliminé avec les ordures ménagères / Non deve essere smaltito con i rifiuti domestici / Mag niet samen met huisvuil weggegooid worden

Transport / Storage Transport / Lagerung Transport / Stockage Transport / Stoccaggio Transport / Opslag

Tested according to IEC 60601-1/A2:1995

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