mamivac SENSITIVE-CFH User manual

SENSITIVE-CFH
Operating instructions – electric breast pump
only for clinical use
REF 286000
As of 2018-12
GB1010029GB
Tel.: [phone] / 1 76 02 - 100
Fax: [phone] / 1 76 02 - 500
[email protected]
KaWeCo GmbH
Gerlinger Str. 36-38
71254 Ditzingen
Germany

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Please read the operating instructions carefully before you use the mamivac®SENSITIVE-CFH
breast pump and keep them together with the device.
Contents
1. Purpose 16
1.1 Indications 16
1.2 Contraindications 16
1.3 Side effects 16
1.4 Suction kits 16
2. Layout and components 17
3. Available accessories 18
3.1 Mobile stand 18
3.2 Components of the mobile stand 18
3.3 Assembling 18
4. Using the breast pump 19
4.1 The mamivac®2-phase technology 19
4.2 The stimulation phase 19
4.3 The expressing phase 20
4.4 Switching off the device 20
5. Hygiene and cleaning 20
5.1 Cleaning and servicing the breast pump 20
5.2 Cleaning and servicing the mamivac®suction kit 20
6. Important safety notes 20
6.1 Note on electromagnetic compatibility (EMC) 21
7. Storage, transportation and ambient conditions 21
8. Warranty 21
9. Practical tips 22
10. Troubleshooting 22
11. Environmental protection and disposal 23
12. Technical data 23
13. Conversion table of units 23
14. Legend 23
15. Accessories and spare parts 24

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1. Purpose
With the mamivac®SENSITIVE-CFH 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-CFH 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.
• This breast pump is for clinical use only. Not intended for home care.
1.1 Indications
The mamivac®SENSITIVE-CFH breast pump is used to gently express and collect milk in case of
breastfeeding problems or other situations where direct breastfeeding is not possible. Medical indications for
using the mamivac®SENSITIVE-CFH breast pump are the following breastfeeding problems:
• mastitis (bacterial inflammation of the mammary glands)
• anatomic variants of the mamillae (flat or retracted nipples) which make latching
and feeding the baby more difficult
• insufficient milk production
• sore mamilla (nipple)
• milk oversupply (excessive milk production, poorly sucking child)
• 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 the baby is contraindicated over a limited period of time
(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 things
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 of the breast pump you need the stipulated original mamivac®suction kits (see
chapter 15). The use of other suction kits represents a significant safety risk. Please connect
mamivac®suction kits to connectors f and/or g). Please see operating instructions for suction kits.

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2. Layout and components
mamivac®SENSITIVE-CFH as table unit
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) Bottle holder
e) LED for mains operation
green = ready for use
f) Connection for suction kit
g) Connection for suction kit
h) Connection for power cord
i) Power cord 3 m (REF 283003)
c
a
b
f
hl
g
g
g
e
d

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3. Available accessories
3.1 Mobile stand
(REF 283012)
• For a fast use of the breast pump in clinical life wherever it is needed
• Mobile, stable base with five legs and five lockable castors
• Height of the mobile stand can be extended from 70 cm to 118 cm.
• For a safe transportation of the device with the mobile stand
make sure that the extension is completely retracted.
3.2 Components of the mobile stand
o) Mobile stand (REF 283012)
p) Cylinder head bolt (REF 49020841)
q) Washer (REF 49026944)
Allen key (REF 49020001)
3.3 Assembling
Use the supplied four washers and the four cylinder head bolts to mount the mamivac® SENSITIVE-CFH to
the metal plate of the clinic stand. Make sure the metal plate fits the dent in the bottom of the breast pump.
q
p
o

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4. Using the breast pump
It is important that the clinic staff carefully instruct any patient in the proper use of the breast pump.
Prior to using the pump, observe the following:
• 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 sterile single-use suction kits
only with original mamivac® protectors or only original mamivac®suction kits.
• Assemble the parts as shown in the operating instructions. See Chapter 5 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.
4.1 The mamivac®2-phase technology
The mamivac®SENSITIVE-CFH breast pump simulates
the baby’s natural sucking behaviour. It can be divided into
two phases (stimulation phase and expressing phase).
4.2 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.
SENSITIVE-CFH
Initiate flow
of milk
Express milk
Let-down reflex

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4.3 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.
4.4 Switching off the device
Turn the vacuum control indicator to . The device is now switched off.
5. Hygiene and cleaning
5.1 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!
5.2 Cleaning and servicing the mamivac®suction kit
• Please observe the operating instructions of the 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.
• 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.
6. 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-CFH 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 clinical use.
• Operate and store the breast pump in dry rooms only.
• Operate the mamivac®SENSITIVE-CFH breast pump only on a flat and stable surface.
• In case of disturbances or failure please contact your rental station/vendor.
SENSITIVE-CFH

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• 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 cord 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.
• 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.
6.1 Note on electromagnetic compatibility (EMC)
The mamivac®SENSITIVE-CFH 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 12 and 15 are used, in an electromagnetic environment that corresponds to that of a domestic envi-
ronment (dwelling, medical practices) where the public power system is available. It is also possible to use the
mamivac®SENSITIVE-CFH breast pump professional health care facilities (hospitals, birth centres, etc.).
It is not permitted to operate the mamivac®SENSITIVE-CFH 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 electromag-
netic 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-CFH breast pump is operated in the specified environment, an impair-
ment of the performance characteristics given in chapter 12 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 immunity 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-CFH breast pump. Non-observance may impair
the performance characteristics of the device.
7. Storage, transportation and ambient conditions
• Avoid strokes or impacts of any kind, regardless of whether the device is packed or not.
• Avoid temperature changes, high air humidity or a dusty environment.
• The device can be operated at an ambient temperature of +10°C to +40°C, a relative humidity
of 30 % to 75 % (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 85 % (non-condensing) 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.
8. Warranty
The warranty period for the mamivac®SENSITIVE-CFH 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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9. Practical tips
Prior to using the pump for the first time and any time afterwards, clean your mamivac
®
suction kit as de-
scribed in the respective operating instructions. 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-CFH 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 4.
• 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.
• Since expressing times strongly depend on the individual mother, you are asked to contact your midwife
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.
10. Troubleshooting
The hygienic diaphragm of the suction kit/protector 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.
Problem Error/solution
Pump does not start
• Use a fully charged battery or change to mains operation
• Check connections between power supply and device
• When mains operated, the LED (e) must light up in green
• Check connections between rechargeable battery and device
• When operated via rechargeable battery, the LED (f) must light up in green
• LED (f) flashes in red (error message) when rechargeable battery is weak.
Switch off the device and remove the rechargeable battery.
• 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.

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11. Environmental protection and disposal
Please dispose of mamivac®SENSITIVE-CFH breast pumps out of order in accordance with your local dis-
posal regulations for electrical devices.
12. Technical data
mamivac®SENSITIVE-CFH: REF 286000 Device classification
Nominal voltage: 100-240 V/AC 50 - 60 Hz Classified acc. to 93/42/EEC
max. 0.62 A Article 9, Appendix IX: Class IIa/Rule 11
H x W x D: 24 cm x 21 cm x 22 cm
Weight: 1.3 kg
Max. vacuum: -5 to -33 kPa (±15%)
Mean vacuum: Device for intermittent sucking without continuous vacuum
Power cord: 2 cores 2 x 0.75 mm; H05VVH2-F 3.0 m long with Euro plug (REF 283003)
Protection class: II
13. 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)
14. Legend
Observe safety instructions Manufacturer
Observe operating instructions Protect from sunlight
Store in dry place
Protection against penetration of solid par-
ticles of a diameter ≥1.0 mm. No protection
against penetration of water.
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
SN
REF
IP40

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15. Accessories and spare parts
Designation REF
mamivac® SENSITIVE-CFH breast pump (device) 281021
mamivac® SENSITIVE-CFH with country-specific power cord (K*) 286000K*
Test unit 2899120
Clinic stand 283012
mamivac®suction kit ECONOMY L 283122
mamivac®double kit ECONOMY L 283124
mamivac®suction kit PREMIUM L 283120
mamivac®double kit PREMIUM L 283123
Breast tube XL for suction kit PREMIUM L 283121
Power cord EU 283003
Power cord UK 287001
Power cord US 287002
Power cord AU 287003
Operating instructions mamivac® SENSITIVE-CFH GB1010029M