Medela Lactina User manual

EFFICIENCY
EN Instructions for use – hospital use | DE Gebrauchsanweisung – Verwendung im Krankenhaus
FR Mode d’emploi –Usage en milieu hospitalier |IT Istruzioni per l’uso –Uso ospedaliero
NL Gebruiksaanwzing – voor gebruik in ziekenhuizen
Lactina®

2Thank you for choosing the Lactina breast pump. Breast milk is the natural choice for newborns, but
there are reasons and situations where breastfeeding is not possible. For over 50 years, it has been
Medela’s conviction that these mothers and infants can be supported. In close co-operation with
breastfeeding experts, Medela, one of the market leaders, has researched and developed breast
pumps that meet breastfeeding mothers’ needs. For mothers who insist on the best for their infants
and themselves.
Medela vous remercie d’avoir choisi le tire-lait Lactina. Le lait maternel est ce qu’il y a de plus naturel
pour les nouveau-nés, mais dans certaines situations, l’allaitement au sein n’est pas possible. Voilà
plus de 50 ans que Medela s’est donné pour mission d’assister ces mamans et ces nourrissons en
difficulté. Medela a mené des recherches et développé des tire-laits qui répondent aux besoins des
mamans allaitantes, en collaboration avec des experts de l’allaitement. Ces appareils s’adressent
aux mamans qui ne veulent que le meilleur pour leur nourrisson et elles-mêmes.
Grazie per aver scelto il tiralatte Lactina. Il latte materno è la scelta naturale per i neonati, ma in alcuni
casi non è possibile allattare al seno. Da oltre 50 anni Medela è impegnata ad aiutare madri e neonati
che si trovano in queste situazioni. In stretta cooperazione con gli esperti dell’allattamento al seno,
Medela, uno dei leader del mercato, ha condotto ricerche volte a sviluppare tiralatte che soddisfino
le esigenze delle mamme. Per madri che esigono il meglio per i loro bambini e per loro stesse.
Hartelijk dank dat je voor de Lactina borstkolf hebt gekozen. Moedermelk is de natuurlijke keuze
voor pasgeboren baby’s, maar er zijn redenen en omstandigheden waarin het niet mogelijk is om
borstvoeding te geven. Medela is er al meer dan 50 jaar van overtuigd dat deze moeders en baby’s
met speciale oplossingen ondersteund kunnen worden. In nauwe samenwerking met
borstvoedingsdeskundigen heeft Medela, een van de marktleiders, borstkolven onderzocht en
ontwikkeld die perfect tegemoetkomen aan de behoeften van moeders die borstvoeding geven.
Voor moeders die het beste willen voor hun baby en voor zichzelf.
Herzlichen Dank, dass Sie sich für die Milchpumpe Lactina entschieden haben. Muttermilch ist
die natürlichste Form der Ernährung für Neugeborene, doch es gibt Situationen, in denen das Stillen
aus verschiedenen Gründen nicht möglich ist. Als einer der Marktführer setzt sich Medela seit über
50 Jahren mit Überzeugung für das Wohl dieser Babys und Mütter ein. In enger Zusammenarbeit mit
Stillexperten hat Medela Milchpumpen erforscht und entwickelt, die auf die Bedürfnisse stillender
Frauen abgestimmt sind. Für Mütter, die nur das Beste für sich und ihr Baby wollen.

EN
4–43
DE
44 – 83
FR
84 – 123
IT
124–163
NL
164–203

Table of Contents
41. Intended use/population / contraindication 5
2. Meaning of symbols 6
3. Important safety information 8
4. Product description 12
5. Cleaning 16
6. Preparing for pumping 26
7. Expression 32
8. Storing and thawing breast milk 38
9. Troubleshooting 40
10. Warranty and maintenance / disposal 41
11. Accessories list 42
12. Cleaning – Country-specic regulations 204
13. EMC/Technical description 207
14. Technical specications 213

The 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 engorge-
ment by expressing milk. In cases 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, if they are travelling, or are otherwise separated from their babies. 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 sucking of a nursing baby.
Contraindications
There are no known contraindications for the Lactina* breast pump.
Product description
Lactina is a exible breast pump with a proven track record through regular use in hospitals
and as a rental pump. It is available as the Lactina Electric Plus and the Lactina Select, both
of which operate using the traditional one-phase pumping technology.
Both Lactina models are suitable for single and double pumping. The accessories set can
also be used as a manual breast pump. Depending on the breast pump model, it is also
possible to set the vacuum level and pump speed.
1. Intended use /population / contraindication
5
* Lactina is a trademark of Medela AG

Warning
Can lead to serious injury or death.
Caution
Can lead to minor injury.
Note
Can lead to material damage.
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 that the device should be kept away from sunlight.
This symbol indicates a fragile device that should be handled with care.
This symbol indicates the temperature limits for operation, transport and
storage.
This symbol indicates the humidity limits for operation, transport and storage.
This symbol indicates the atmospheric pressure limits for operation,
transport and storage.
This symbol indicates that the device should be kept 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).
2. Meaning of symbols
The warning symbol identies 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:
i
i
6

Symbols on the device
This symbol indicates that the instructions for use should be followed.
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.
This 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 the manufacturer's catalogue number for the device.
This symbol indicates 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).
This symbol indicates a class II protection against electric shock with double
or reinforced insulation.
This symbol indicates the fuse (to identify fuse boxes or their location).
This symbol indicates that the fuse box is safety tested.
7

3. Important safety information
83.1 Warnings
Failure to follow the instructions/safety information below can lead to danger from
the device. Subject to technical changes.
READ ALL INSTRUCTIONS BEFORE USE
WARNING: To reduce the risk of electrocution:
l Keep the device dry. Never immerse in water or other liquids!
l Do not spray or pour liquid directly onto the pump unit.
l Do not place or store the device where it can fall or be pulled into a sink or tub.
l Do not use the Lactina breast pump while bathing or showering.
l Do not reach for any electrical device if it has fallen into water. Unplug immediately.
l Always unplug the Lactina breast pump immediately after use.
WARNING: To avoid re, electrocution or serious burns:
l The Lactina breast pump is not heat-resistant: keep away from radiators and open
ames.
l Do not expose the motor unit to direct sunlight.
I Do not operate the Lactina breast pump where aerosol (spray) products are being used
or where oxygen is being administered.
I Do not use the device in the presence of a ammable anaesthetic mixture with air,
or with oxygen or nitrous oxide.
I Do not thaw frozen breast milk, or do not warm breast milk in a microwave or in a pan of
boiling water. Microwaving can cause severe burns to the baby’s mouth from hot spots
that develop in the milk during microwaving. Microwaving can also change the composi-
tion of breast milk.
IUse only the power cord that comes with the Lactina breast pump. Make sure the
voltage of the power cord is compatible with the power source.
l Never operate an electrical device if it has a damaged power cord, if it is not working
properly, if it has been dropped or damaged, or dropped into water.
I Always inspect power cord wires prior to use for damage or exposed wire. If any
damage is found, immediately stop using the power cord. Contact the local Medela
representative.

3. Important safety information
9
l The Lactina breast pump should never be left unattended when plugged into
a power source.
l Separation from the mains is only assured by disconnecting the power cord from
the wall socket.
l Position the pump unit such that it is easy to disconnect the power cord from
the wall socket.
l Keep the power cord away from heated surfaces.
WARNING: To avoid health risk and reduce risk of injury:
IReprocess all reusable parts that come in contact with the breast and breast milk prior
to rst use as shown in chapter 5.2.
I Clean parts that come in contact with the breast and breast milk immediately
after use.
I If breast milk overow occurs, reprocess according to the instructions
in chapter 5.2.
IThe pump sets are personal care items intended for use by a single user only.
They should not be shared between mothers without appropriate reprocessing to
minimise the risk of cross-contamination.
I Do not continue pumping for more than 2 consecutive pumping sessions if no results are
achieved.
IIf problems or pain occur, consult a lactation specialist.
I Never use while pregnant, unless prescribed/advised by a physician, as pumping can
induce labour.
I For mothers who are infected with Hepatitis B, Hepatitis C or Human Immuno-
deciency Virus (HIV): pumping breast milk will not reduce or remove the risk of
transmitting the virus to the baby through breast milk.
I Inspect all components of the Lactina breast pump as well as all parts of the pump set(s)
before each use.
l Never use a device, components or parts that are damaged.
l Never use a device, components or parts if dirt, mould or other contamination is
visible.
l Replace mouldy, damaged or worn parts.
l There are no user-serviceable parts inside the Lactina pump unit. Repairs must be
performed only by an authorised service agency. Do not repair the parts yourself!
No modications to the device are permitted.
l Use the Lactina breast pump only for its intended use as described in this manual.

1. Intended Use/Contraindication/Population
3. Important safety information
WARNING: To avoid health risk and reduce risk of injury:
l Use Medela original accessories only.
l Do not use attachments not recommended by Medela, as this may cause hazards.
l Do not modify any parts of the pump or the pump set.
l Do not use the Lactina breast pump while sleeping or overly drowsy.
l Do not use the Lactina breast pump while operating a motor vehicle.
l Do not drive whilst hands-free pumping.
l Never drop or insert any object into any opening or tubing.
l Do not use outdoors.
l Supervision is necessary when the Lactina breast pump is used in the vicinity of children.
l Portable and mobile radio frequency communications equipment can affect the
Lactina 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.
3.2 Cautions
Failure to follow the instructions/safety information below can lead to minor injury.
Subject to technical changes.
CAUTION: To avoid risk of contamination:
I Wash hands thoroughly with soap and water before touching the breast pump,
the pump set(s) and breasts. Avoid touching the inside of containers or lids.
I Only use drinking-quality tap or bottled water for cleaning.
I Do not store wet or damp parts as mould may develop.
10

1. Intended Use/Contraindication/Population
3. Important safety information
CAUTION: To avoid health risk and reduce risk of injury:
IPump only with the breast pump in an upright position.
I Pressing shields too rmly onto the breasts may affect the milk ow.
I Do not express with a vacuum that is too high and uncomfortable (painful). The pain,
along with potential breast and nipple trauma, may decrease the milk output.
I Do not attempt to remove the breast shield from the breast while pumping. Turn the
breast pump off and break the seal between the breast and the breast shield with the
nger, then remove the breast shield from the breast.
IIf pumping is uncomfortable or causing pain, turn the unit off, break the seal between the
breast and the breast shield with the nger and remove the breast shield from the breast.
I Do not shorten the tubing between the breast shield and the pump.
I Do not use abrasive washing-up liquids/detergents when cleaning the breast pump,
pump components or pump set parts.
I Never put the breast pump unit in water or in a steriliser, as this can cause permanent
damage to the breast pump.
I Do not use the Medela Lactina pump sets with a non-compatible breast pump.
I Do not use the pump sets for any other purpose than expressing breast milk.
CAUTION: To reduce risk of electrocution:
I Plug the power cord into the breast pump rst and then into the wall socket.
IUnplug the breast pump before cleaning.
I The Lactina breast pump needs special precautions regarding EMC (Electro Magnetic
Compatibility). Install and put into service according to the EMC information provided in
these instructions for use.
11

4. Product description
12 4.1 Lactina hospital breast pump and accessories 12
Lactina is a exible breast pump with a proven track record through regular use in hospitals
and as a rental pump. It is available as the Lactina Electric Plus and the Lactina Select, both
of which operate using the traditional one-phase pumping technology. Both Lactina models
are suitable for single and double pumping. The accessories set can also be used as a
manual breast pump. Depending on the breast pump model, it is also possible to set the
vacuum level and pump speed.
Required accessories*
The Lactina breast pump should be operated with Medela pump sets and milk bottles. The
pump sets and the bottles are available as reusable or as disposable products.
Reusable products:
I Lactina Hospital Multibox (50 reusable single pump sets)
Disposable products:
Medela’s disposable products are intended for single-use or one-day use in hospitals, without
a need for cleaning prior to rst use:
Medela’s Ready-to-Use products are hygienically safe to use without prior
cleaning, for all hospitals where the use of non-sterile products is allowed.
Medela’s sterile products are EO sterile and fulll the EN/ISO standards for medical
devices ISO 11607-1, ISO 11607-2, ISO 11135-1.
Available disposable products:
I Lactina One-Day Pump Set with PersonalFit breast shield (size M, L or XL)
I Sterile Single-Use Lactina Pump Set (size M, L or XL)
I Ready-to-Use One-Day Lactina Pump Set (size M, L or XL)
I Colostrum Container (35 mL)
I Sterile Single-Use Bottle (available sizes: 80, 150 and 250 mL)
I Ready-to-Use Single-Use Bottle (available sizes: 80, 150 and 250 mL)
Optional accessories*
Mobile stand for the breast pump, carrying case, car connection cable and test
vacuum meter.

1313
4.2 Lactina hospital breast pump – Product parts*
Lactina Select Lactina Electric Plus
The Lactina Select has an additional knob for adjusting the pump
speed between 40 and 60 cycles per minute. Select a fast pumping
rhythm to stimulate the milk ow. Reduce the speed when the milk
begins to ow.
Socket for car
connection cable
Power cord
Bottle holder
* See chapter 11 for ordering information for accessories
Speed adjust knob
Only Lactina Select

4. Product description
1x piston
1x PersonalFit
connector
1x valve head 2x valve
membrane
1x breast milk bottle
(150mL)
1x cylinder holder
1x silicon tubing
(105cm)
1x stand for
150mL bottle 1x port cap
1x vacuum regulator ring
1x PersonalFit
breast shield
1x rubber seal
1x cylinder
14
1x protective cap 1x disc 1x lid with opening
4.3 Reusable pump set – Product parts (applied parts)*
* See chapter 11 for ordering information

4. Product description
15
1x breast shield
1x silicone tubing
1x piston
1x cylinder holder
1x port cap
1x vacuum
regulator ring
1x cylinder
1x rubber seal
disposable
bottle
250mL
disposable
bottle
150mL
disposable
bottle
80mL
colostrum
container
35mL
1x connector
1x membrane
4.4 Disposable pump set – Product parts (applied parts)*
* See chapter 11 for ordering information

1. Intended Use/Contraindication/Population
5. Cleaning
16 5.1 Breast pump – Cleaning
and disinfection
To clean the breast pump, wipe the
pump housing with a clean, damp
(not wet) cloth. Drinking-quality water
and a basic washing-up liquid or non-
abrasive detergent may be used.
lUnplug the breast pump before cleaning.
IThese recommendations are not
substitutes for ofcial hospital procedures
that may differ among institutions. Refer to
hospital policy for cleaning of shared
capital equipment.
I Surface disinfectant agents for medical
devices will not cause mechanical damage
to the Lactina.
I Follow the instructions provided by the
supplier of the surface disinfectant agents.
I Provide personal protection for operators
in accordance with the supplier’s
instructions and safety data sheets.
I Check the suitability of the surface
disinfectant agents for medical devices
by reference to the supplier’s information
and/or physical testing.
Caution
Clean and disinfect the breast pump as
needed.
1

1. Intended Use/Contraindication/Population
17
2
To disinfect the pump, wipe the
pump housing with a clean, damp (not
wet) cloth that is impregnated with a
surface disinfectant agent for medical
devices. Medela recommends using
a surface disinfectant agent that is
alcohol based.
5.2 Cleaning pump sets –
Overview
The table on the following pages shows
when to clean, disinfect and sterilise the
bottles, pump sets and the tubing. These
are general instructions. For country-
specic regulations and guidelines, see
chapter 12.
The listed automated reprocessing
pro cedures are tested, validated and
recommended by Medela. In the case
of automated cleaning, an internal
validation of the preferred procedure by
the hospital is necessary, too. In the
event of conicting national cleaning and
sterili sation requirements, these shall
prevail over the Medela recommenda-
tions.
1
2

1. Intended Use/Contraindication/Population
5. Cleaning
18 5.2 Cleaning pump sets – Overview
Disposable bottles1) and disposable pump sets
(breast shield, connector, membrane, silicone tubing)
Single-use pump set and
single-use bottles One-day pump sets
Before rst use No cleaning needed No cleaning needed
After every use2) Dispose of after use (§5.3)
I Manual cleaning (§5.4)
Note: Tubing must
not be cleaned.
Once a day n/a
Dispose of after a maximum of
8 pumping sessions within 24 hours
(§5.6).
Before passing
on to the next
mother
n/a n/a
1) All disposable bottles (sterile and Ready-to-Use) are single-use products. They must not be reprocessed.
2) As long as the pump sets stay with the mother.

1. Intended Use/Contraindication/Population
19
2) As long as the pump sets stay with the mother.
3) If there is milk, condensation or visible residues in the tubing, the tubing must be disposed of and replaced.
Medela recommends that the tubing is disposed of and replaced after max. 6 months.
4) If required by national, regional or in-house regulations.
Reusable bottles and
reusable pump sets
(breast shield, connector, valve head,
valve membrane, port cap, cylinder
holder, vacuum regulator ring, cylin-
der, rubber seal, piston)
Reusable pump sets:
silicone tubing
Before rst use
I Automated cleaning and disinfection
(§5.8) or
I Automated cleaning and disinfection
(§5.8) and sterilisation4) (§5.9)
Wipe disinfection (§5.7)
After every use2)
I Manual cleaning (§5.7) or automated
cleaning and disinfection (§5.8)
I Sterilisation4) (§5.9)
No cleaning needed3)
Once a day2)
I Manual cleaning (§5.7) or automated
cleaning and disinfection (§5.8)
I Sterilisation4) (§5.9)
No cleaning needed3)
Before passing
on to the next
mother
I Automated cleaning and disinfection
(§5.8)
I Sterilisation4) (§5.9)
Wipe disinfection3) (§5.7)

1. Intended Use/Contraindication/Population
5. Cleaning
20
3
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. It is
important that all residual moisture
dries. Do not store parts in an airtight
container/bag.
5.3 Disposable single-use
pump sets and bottles –
Cleaning
The sterile pump set and disposable
bottles (sterile and Ready-to-Use) are
single-use products that may not be
reused or reprocessed.
Dispose of the pump set and bottle
after use. Use a new pump set and
bottle for each pumping session.
Drying / storage
l Only use drinking-quality water for cleaning.
lTake apart and wash all parts of the
one-day pump set that come into contact
with the breast and breast milk immediately
after use to avoid milk residues drying up
and to prevent growth of bacteria.
Caution
i
l The pump sets require no maintenance.
lTake care not to damage parts of the
one-day pump set during cleaning.
l You can use a one-day pump set for up to
eight pumping sessions within 24 hours.
For more information, see the pump set’s
instructions for use.
Note
l The sterile single-use pump set is a single-
use product and may not be reused or
reprocessed.
l The one-day pump set is a single-user
product. It is not possible to disinfect and
autoclave the pump set for safe re-use be-
tween multiple users. Use by more than one
person may present a health risk and could
cause cross-contamination.
l The disposable bottles (sterile and Ready-
to-Use) are single-use products that may
not be reused or reprocessed.
l Clean parts that come in contact with the
breast and breast milk immediately after use.
Warning