KaWeCo MAMIVAC SENSITIVE-C User manual

SENSITIVE-C
Operating instructions – electric breast pump
for rental
Phone: [phone] / 1 76 02 - 100
Fax: [phone] / 1 76 02 - 500
[email protected]
KaWeCo GmbH
Gerlinger Str. 36-38
71254 Ditzingen
Germany
REF 284000
As of 2018-12
GB1010002GB

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Please read the operating instructions carefully before you use the mamivac®SENSITIVE-C
breast pump and keep them together with the device.
Contents
1. Purpose 15
1.1 Indications 15
1.2 Contraindications 15
1.3 Side effects 15
1.4 Suction kits 15
2. Layout and components 16
3. Using the breast pump 17
3.1 Prior to using the pump 17
3.2 The mamivac®2-phase technology 17
3.3 The stimulation phase 17
3.4 The expressing phase 17
3.5 Switching off the device 18
4. Hygiene and cleaning 18
4.1 Cleaning and servicing the breast pump 18
4.2 Cleaning and servicing the mamivac®suction kit 18
5. Important safety notes 18
5.1 Note on electromagnetic compatibility (EMC) 19
6. Storage, transportation and ambient conditions 19
7. Warranty 19
8. Practical tips 20
8.1 Storing breast milk 20
9. Troubleshooting 20
10. Environmental protection and disposal 21
11. Technical data 21
12. Conversion table of units 21
13. Legend 22
14. Accessories and spare parts 22

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1. Purpose
With the mamivac®SENSITIVE-C breast pump, milk can be expressed and collected gently when
breastfeeding problems occur. Breastfeeding problems may be caused by the mother herself or the
baby. Using the mamivac®SENSITIVE-C electric breast pump, you can:
• increase milk production by completely emptying the breast.
• maintain the breastfeeding option for the baby to continue normal breastfeeding after
breastfeeding problems.
mamivac®SENSITIVE-C is intended for rental and for home use.
1.1 Indications
The mamivac®SENSITIVE-C breast pump is used to gently express and collect milk in case of breast-
feeding problems or other situations where direct breastfeeding is not possible. Medical indications
for using the mamivac®SENSITIVE-C breast pump are the following breastfeeding problems:
• mastitis (bacterial inflammation of the mammary glands)
• sore mamillae (nipples)
• anatomic variants of the mamillae (flat or inverted nipples) which make feeding the baby more difficult
• milk oversupply (excessive milk production, poorly sucking child)
• insufficient milk production
• premature babies (poorly sucking premature infant or separation of infant from mother)
• metabolic disorders of the baby
• anatomic disorder in the face of the infant (cleft lip, jaw, palate)
• diseases of the mother where breastfeeding is temporarily contraindicated (e.g. taking medicine).
1.2 Contraindications
A possible contraindication is being allergic to the silicone of the soft insert which is in direct contact
with the skin. When taking specific medicine, breastfeeding the infant is also contraindicated
since pharmacologically effective substances can pass through the milk. For information about
possible contraindications for breastfeeding, refer to the Patient Information Leaflet provided by the
pharmaceutical company. When medication is limited to a specific period of time, expressing the milk
with a breast pump helps to maintain milk production over this period.
mamivac®pumps may not be used:
• to suction other body fluids, such as blood, secretions or mucus.
• to suction outside the medical field, such as corrosive, flammable or explosive liquids.
• on other living beings.
1.3 Side effects
• In individual cases, the skin may be irritated resulting in redness or red spots.
• In case of a known silicone allergy, do not use the silicone soft insert. The silicone soft insert
is part of some mamivac®suction kits.
1.4 Suction kits
For the intended use, you need the stipulated suction kits.

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2. Layout and components
a) Continuously adjustable vacuum control
b) Continuously adjustable cycle control
c) Status LED
flashing green = ready for use
yellow = self-testing
red = error message
d) Connection for power unit
e) Connection for suction kit
f) Connection for second suction kit
g) Sliding cover
h) Power unit, EU version (24 W)
with cable to pump
f
a
b
c
h
d
g
e

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3. Using the breast pump
3.1 Prior to using the pump
• Pay special attention to cleanliness. Prior to expressing, always wash your hands thoroughly with soap
and wipe the breast with a damp cloth.
• To avoid malfunction and ensure a proper functioning, use the original mamivac®suction kits (patient
applied part) exclusively.
• Assemble the parts as shown in the operating instructions.
• See Chapter 4 for notes on cleaning and disinfecting.
• Please use air tubes with the following dimensions only:
5.5 mm outside Ø, 2.5 mm inside Ø, about 1 m long.
3.2 The mamivac®2-phase technology
The mamivac®SENSITIVE-C breast pump simulates the baby’s natural
sucking behaviour. It can be divided into two phases (stimulation phase
and expressing phase).
3.3 The stimulation phase
100 cycles; fast cycles, low vacuum
Imitates the baby’s sucking which is fast, but weak in the beginning.
The short cycles stimulate the flow of milk.
• Turn on the pump by switching the vacuum control to .
Make sure that the vacuum control indicator is in the area marked green
(low vacuum).
• Turn the cycle control to a high cycle number of about 100 cycles
(see figure).
Make sure that the cycle control indicator is in the area marked green
(fast cycles).
• When the milk starts to flow, after two minutes at the latest,
switch to the expressing phase, (20-60 cycles; slow cycle, higher vacuum).
A beep will sound after 2 minutes to remind you.
3.4 The expressing phase
20-60 cycles; slow cycles, higher vacuum
When the flow has been stimulated, the milk starts to flow. Now you can express
the milk very gently and efficiently.
• Turn the cycle control indicator to the area marked grey (slower cycles).
• Turn the vacuum control indicator to the area marked grey (higher vacuum).
• In the expressing phase, both the cycle speed and the vacuum strength can
be continuously adjusted.
• In general, it is recommended to reduce the cycle speed when increasing
the vacuum.
Initiate flow
of milk
Express milk
Let-down reflex

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3.5 Switching off the device
Turn the vacuum control indicator to . The device is now switched off.
4. Hygiene and cleaning
4.1 Cleaning and servicing the breast pump
• When the pump is not in use or when it is cleaned, always disconnect it from mains supply.
In case of problems, also disconnect the pump immediately by all means.
• Do not use aggressive detergents (solvents, etc.) to clean the casing, but a cloth damped with a
light soap sud.
• Make sure that no liquid enters the device. Wipe over the parts with a dry cloth. For a disinfection
of the casing, you can use alcohol-based disinfectants.
Do not rinse the pump!
4.2 Cleaning and servicing the mamivac®suction kit
• Do not use chemical disinfection baths, solvents or abrasives.
• All parts of the mamivac®suction kits, except for the air tube and the tube connection, can be
cleaned by hand with commercial washing-up liquids or in the dish washer or boiled out in a pot at
100 °C for 15 minutes.
• Prior to using the kit the next time, clean the parts which came into contact with milk. With the
mamivac®suction kits, it is not necessary to clean the air tube or tube connection. It is sufficient to
wipe off these parts with a damp cloth. If too much milk enters the bottle, the milk could be sucked
up to the protective diaphragm. Switch off the pump immediately. Remove the tube connection imme-
diately from the pump which will release the existing vacuum in the breast shield to prevent damage to
the tissue.
• After cleaning, rinse all parts thoroughly with lukewarm water to remove residues of the washing-up
liquid, especially on those components which come into direct contact with breast milk. You might use a
brush to clean areas which are difficult to reach.
• Please observe the operating instructions of the suction kit. The suction kit can be used, cleaned and
disinfected for at least 50 times.
5. Important safety notes
• Make sure that the supplied voltage matches the voltage stated on the power unit or is within
the limits.
• Do not operate the mamivac®SENSITIVE-C breast pump in operating rooms or in rooms with
explosion risk. The breast pump is not designed to be used outdoors or during transportation.
• The breast pump is intended for rental.
• Operate and store the breast pump in dry rooms only.
• Operate the mamivac®SENSITIVE-C breast pump only on a flat and stable surface.
• In case of disturbances or failure please contact your rental station/vendor.
• If you think a safe operating is no longer ensured, e.g. in case of a faulty insulation of the power
cord or faulty cord between the power unit and the device, discontinue the operation of the device
immediately (unplug power unit from wall outlet) and secure it against putting into operation again.
Unplugging is the only means to safely disconnect the device from the mains supply.
• Any modifications/manipulations of the device or its accessories, or a combination with other devices
and/or systems or components make a safe use impossible and are therefore strictly forbidden.

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• Prior to using the device, check the milk bottle for cracks and exchange it if need be. A frequent boiling
of the milk bottle and the parts of the suction kit may cause a brittling of the plastic material resulting in
cracks. Porous parts shall be replaced by new parts.
• Small parts are enclosed to the product which could be inhaled or swallowed. Keep them away from
toddlers/children.
5.1 Note on electromagnetic compatibility (EMC)
The mamivac®SENSITIVE-C breast pump described in these instructions for use may only be operated
in accordance with the following information, provided that the accessories and spare parts mentioned
in chapters 11 and 14 are used, in an electromagnetic environment that corresponds to a domestic environ-
ment (dwelling, medical practices) where the public power system is available.
It is not permitted to operate the mamivac®SENSITIVE-C breast pump in means of transportation, be
it over land, across water or through the air, nor in special-use HF shielded rooms (e.g. MRT) where elec-
tromagnetic bursts of high intensity may occur nor in the immediate vicinity of active HF surgery devices or
shortwave therapy devices.
For a detailed technical description of the electromagnetic environment, visit
https://www.mamivac.com/en/knowledge/download
Provided that the mamivac®SENSITIVE-C breast pump is operated in the specified environment, an im-
pairment of the performance characteristics given in chapter 11 or the basic safety is not to be expected.
WARNING: Avoid using this device directly next to other devices or with other devices stapled on top of
each other as this could disturb operation.
WARNING: The use of accessories, converters or cables other than those defined or provided by KaWeCo
for this device can lead to an increased electromagnetic interference or a reduced electromagnetic immu-
nity of the device resulting in faulty operation.
WARNING: Portable HF communication devices (transmitters), including their accessories such as
antenna cables and external antennas, shall not be used within a distance shorter than 12 inches (30 cm)
to the parts and cables listed by KaWeCo for the mamivac®SENSITIVE-C breast pump. Non-observance
may impair the performance characteristics of the device.
6. Storage, transportation and ambient conditions
• Avoid strokes or impacts of any kind, regardless of whether the device is packed or not.
• Avoid rapid temperature changes, high air humidity or a dusty environment.
• The device can be operated at an ambient temperature of +5 °C to +40 °C, a relative humidity of
15 % to 93 % (non-condensing) and an air pressure of 700 hPa to 1060 hPa.
• Store and transport the device at an ambient temperature of -29°C to +60 °C, a relative humidity
of max. 85 % and an air pressure of 500 hPa to 1060 hPa.
• An excessive accumulation of lint and dust in the inside of the device impairs heat dissipation of
components, which may overheat as a result representing a fire hazard.
7. Warranty
The warranty period for the mamivac®SENSITIVE-C breast pump is 36 months from the date of purchase.
Improper use, opening the device or using suction kits not specified for this breast pump will void
any warranty claims.

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8. Practical tips
Prior to using the pump for the first time and after every usage, clean your mamivac®suction kits as
described in the respective operating instructions. Please check whether all parts are undamaged. Make
sure to assemble the parts properly again as shown in the instructions. Prior to expressing, always wash
your hands thoroughly with soap and wipe the breast with a damp cloth. To avoid dry, sore or cracked
nipples, do not use soap or alcohol as detergent. Prepare yourself for the expressing with ease. Take a
comfortable and relaxed seat.
• Gently press the breast shield over the nipple for a tight contact.
• You can operate the mamivac®SENSITIVE-C breast pump either with one or two suction kits. To save
time, it is possible to express both breasts simultaneously (double pumping).
• Start to express milk. Please observe the instructions for operating explained in Chapter 3.
• The pump features a stimulation mode to support milk production. You can also use your free hand for
an additional breast massage to support the flow of milk.
• Express both breasts alternately, unless instructed otherwise by your physician.
• When expressing make sure not to overfill the milk bottle. With a capacity of 125 ml, we recommend
to interrupt expressing when the 100 ml mark is reached and fill the expressed breast milk to another
container/bottle. Turn the bottle counterclockwise to unscrew it from the breast shield.
• For further information regarding breast shield size please ask your lactation consultant or midwife.
• Since expressing times strongly depend on the individual mother, you are asked to contact your midwi-
fe or breastfeeding assistant. As a rule of thumb, the following expressing times are recommended:
With one suction kit:
Expressing scheme: Express first and second breast 5 minutes each one after the other, followed by
3 minutes and 2 minutes each.
With two suction kits:
Express both breasts simultaneously for 10 minutes (double pumping). Have a look at the fill level of
the bottle at the suction kit from time to time and make sure it does not overflow.
8.1 Storing breast milk
Breast milk can be stored as follows:
• Freshly expressed milk at room temperature (16°-29°C) 3-4 hours
• In the rear of the fridge (below 4 °C) 3 days
• In the freezer (-18°C) 6 months
Fill the used bottles or containers to two thirds only and write down the fill date. Instead of a bottle, you can
also use our specially designed mamivac®breast milk freezer bags [REF 282100]. Do not defrost frozen
breast milk in the microwave, but at room temperature. Place the bottle or bag in warm water as required.
After defrosting, gently shake the container or bag to mix the milk.
9. Troubleshooting
The hygienic diaphragm of the suction kit effectively prevents that liquids or solids are sucked into the pump.
If substances are sucked in nevertheless or any other problem occurs, immediately put the device out of
operation. Contact your rental station or directly the manufacturer’s customer service.

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Problem: Error / solution
Pump does not start • Check connections between power supply and device
• When mains operated, the LED (c) must light up in green
• If you cannot solve the problem, return the device.
Pump does not suck
(does not build up
vacuum)
• Status LED (c) lights up in red (error message)
• Try to switch off and on the device several times. Wait a minute before
switching on again. After five unsuccessful attempts, return the device to the
manufacturer.
• Check the suction kit:
• Check breast shield valve (for cracks and soiling)
• Check protective diaphragm for cracks
• Protective diaphragm must be inserted flush and crinkle free
• Check tube connections
The breast pump/power unit must not be opened by users/patients. For maintenance and repair
work, the device must be returned to the manufacturer.
10. Environmental protection and disposal
Please dispose of mamivac®SENSITIVE-C breast pumps in accordance with your local disposal regulations
for electrical devices.
11. Technical data
The expected service life is 5 years.
Pump mamivac®SENSITIVE-C: REF 281012 Device classification:
Nominal voltage: 12 V DC Classified acc. to 93/42/EEC,
Power consumption: 1.25 A Appendix IX, Rule 11: Class IIa
H x W x D (mm): 190 x 112 x 145
Weight: 790 g
Max. vacuum: -33 kPa (±15 %)
Mean vacuum: Low flow intermittent sucking without continuous vacuum
Power unit (24 W): REF 283008 EU version
(exchangeable plug-in adapters available on request)
Nominal input voltage: 100-240 V AC 50 / 60 Hz
Input current: max. 550 mA
Output voltage: 12 V DC
Output current: 2000 mA
Protection class: II
H x W x D (mm): 110 x 40 x 80
Weight: 186 g
12. Conversion table of units
1 kPa corresponds: 0.01 bar
0.14504 PSI corresponds: 7.5006 mmHg
(pounds per square inch) (millimetre mercury, at 0°C)

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13. Legend
Observe safety instructions Manufacturer
Observe operating instructions Protect from sunlight
Store in dry place
Protection against penetration of solid
particles of ≥1.0 mm diameter and vertically
falling water drops
Conformity mark according to
EU Council Directive 93/42/EEC Direct current
Device of protection class II Alternating current
Patient applied part of type BF Do not dispose in domestic waste
On Serial number
Off Item number
Observe operating instructions
14. Accessories and spare parts
Designation REF
mamivac® SENSITIVE-C breast pump (device) 281012
mamivac®suction kit PREMIUM L 283120
mamivac®double kit PREMIUM L 283123
mamivac®suction kit PREMIUM XL 283133
mamivac®suction kit PREMIUM S 283129
Power unit for SENSITIVE-C 283008
Power unit for SENSITIVE-C UK 283008K01
Power unit for SENSITIVE-C US 283008K02
Power unit for SENSITIVE-C AU 283008K03
Operating instructions mamivac® SENSITIVE-C GB1010002M
mamivac®suction kit ECONOMY L, small bottle 283122
mamivac®double kit ECONOMY L, small bottle 283124
mamivac®carrying case SENSITIVE-C 283011
mamivac®carrying bag SENSITIVE-C 283010
mamivac®Test unit 2899120
SN
REF
IP41