BREAST FEEDING kitett FISIO User manual

Création FD/SS 01.2000
Ind. 15 MPS 11.10.2018
K.NU.EN.024.1018
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BR RE EA AS ST T F FE EE ED DI IN NG G
INSTRUCTIONS FOR USE
E EL LE EC CT TR RI IC C B BR RE EA AS ST TP PU UM MP P
M
Mo od de el l: :
FISIO
0459 (2003)
Directive 93/42/CEE - Medical devices Class IIa
All KITETT breastpump accessories are BPA free
LA DIFFUSION TECHNIQUE FRANCAISE
19, rue de la Presse CS 60132 42003 SAINT-ETIENNE Cedex 1 France
Tel. + 33.4.77.74.51.11 - Fax + 33.4.77.79.67.72 - e-mail : [email protected] -www.dtf.fr

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C
CO ON NT TE EN NT TS S
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1. . C CL LA AS SS SI IF FI IC CA AT TI IO ON N A AN ND D E EL LE EC CT TR RO OM MA AG GN NE ET TI IC C C CO OM MP PA AT TI IB BI IL LI IT TY Y
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2. . P PR RE ES SE EN NT TA AT TI IO ON N A AN ND D I IN ND DI IC CA AT TI IO ON NS S
2.1. Breastpump with automatic control
2.2. Identification
2.3. Symbols used
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3. . P PR RE EC CA AU UT TI IO ON NS S F FO OR R U US SE E
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4. . T TE EC CH HN NI IC CA AL L D DE ES SC CR RI IP PT TI IO ON N a an nd d P PE ER RF FO OR RM MA AN NC CE ES S
4.1. Operating characteristics
4.2. KFISIO(V)
4.3. List of accessories and spare parts
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5. . I IN NS ST TR RU UC CT TI IO ON NS S F FO OR R U US SE E
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6. . C CL LE EA AN NI IN NG G A AN ND D D DI IS SI IN NF FE EC CT TI IN NG G
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7. . F FA AI IL LU UR RE ES S R RE EM ME ED DI IE ES S A AN ND D W WA AR RR RA AN NT TY Y
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8. . W WA AS ST TE E D DI IS SP PO OS SA AL L

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1
1. . C CL LA AS SS SI IF FI IC CA AT TI IO ON N
Medical device class IIa
Medical device class 2 (electrical safety)
Type BF
Level of protection IP 30:
- protected against ingress of solid foreign objects larger than 2.5 mm;
- not protected against vertical water drops falls.
Device not to be used in presence of a mixture of inflammable anesthetic with air or oxygen or nitrous
oxide.
Expected shelf life of accessories: 1 year.
Expected shelf life of the device: 5 years.
Operating conditions:
TRANSPORT and STORAGE
OPERATING
Room temperature
+ 70 °C
- 25 °C
+ 40 °C
+ 5 °C
Relative humidity
93 %
15 %
93 %
15 %
Atmospheric pressure
1060 hPa
700 hPa
1060 hPa
700 hPa
Essential performances:
Provide sufficient suction for mothers to express milk,
Control the pumping rhythm to better respect the baby's sucking rhythm.
Applied part: Expression Kit Kolor®
Note: the CE declaration is available on request.
ELECTROMAGNETIC COMPATIBILITY
Electro medical devices require special precautions against EMC and must be installed and set to operate
in accordance with the EMC information provided in this manual.
WARNING: Avoid using this unit near or stacked onto other equipment as this may cause a malfunction. If
this is necessary, this appliance and the other appliances should be monitored for normal operation.
WARNING: Use of accessories, transducers and cables other than those specified or supplied by the
manufacturer of this device may cause an increase in electromagnetic emissions or a decrease in the
immunity of this device and cause improper operation.
WARNING: Portable RF communication devices (including peripherals such as antenna cables and
external antennas) should not be used closer than 12 inches (30 cm) to any part of the FISIO breast
pump, including cables specified by the manufacturer. Otherwise, performance may be impaired.
WARNING: If the device malfunctions due to electromagnetic disturbances, the performance of the
device may be impaired and result in delayed patient care.
Wireless communication devices such as wireless home networking devices, mobile phones, cordless
phones and their bases, walkie-talkies can affect the device, and it is recommended to keep them at a
distance of at least 0.5 m from the device.

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Bottle
Comfort breast
shield with
integrated
gasket
Tube
connection
Guidance and manufacturer's declaration –electromagnetic emissions
Emissions test
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 61000-3-3
Complies
Guidance and manufacturer's declaration –electromagnetic immunity
Immunity test
IEC 60601
test level
Compliance level
Electrostatic discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV
± 15 kV
Electrical fast transient / burst
IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input/output lines
± 2 kV
± 1 kV
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Voltage dips, short interruptions
and voltage variations on power
supply input lines
IEC 61000-4-11
0% UT; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
0% UT; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
0% UT; 1 cycle
AND 70% UT; 25/30 cycles
Single phase : at 0°
0% UT; 1 cycle
AND 70% UT; 25/30 cycles
Single phase : at 0°
Voltage interruptions
IEC 61000-4-11
0% UT: 250/300 cycles
0% UT: 250/300 cycles
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
30 A/m
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2,7 GHz
10 V/m
80 MHz to 2,7 GHz
385 MHz at 27 V/m
450 MHz at 28 V/m
710, 745, 780 MHz at 9 V/m
810, 870, 930 MHz at 28 V/m
1720, 1845, 1970 MHz at 28 V/m
2450 MHz at 28 V/m
5240, 5500, 5785 MHz at 9 V/m
385 MHz at 27 V/m
450 MHz at 28 V/m
710, 745, 780 MHz at 9 V/m
810, 870, 930 MHz at 28 V/m
1720, 1845, 1970 MHz at 28 V/m
2450 MHz at 28 V/m
5240, 5500, 5785 MHz at 9 V/m
Conducted RF
IEC 61000-4-6
3V
0,15 MHz –80 MHz
6V in ISM bands and amateur radio bands
between 0.15 MHz and 80 MHz
80% MA at 1kHz
3V
0,15 MHz –80 MHz
6V in ISM bands and amateur radio bands
between 0.15 MHz and 80 MHz
80% MA at 1kHz
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2. . P PR RE ES SE EN NT TA AT TI IO ON N A AN ND D I IN ND DI IC CA AT TI IO ON NS S
Your KITETT® electric breastpump allows an easy collection of the mother's milk.
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IN ND DI IC CA AT TI IO ON NS S
: This KITETT® electric breastpump is also designed for medical purpose, as engorged,
painful or swollen breast.
It is supplied either with:
asingle Expression Kit KOLOR® with integrated Small or Large
comfort shield, interface bottle, (autoclavable Kit on request)
or a double Expression Kit KOLOR® with two Small or Large
comfort shields, interface bottle, (autoclavable Kit on
request)

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Composition of KITETT accessories (BPA free):
K21ES, K2E1L, K24ES, K24EL, K26ES, K26EL, K30ES, K30EL, K21ESD, K21ELD, K24ESD, K24ELD, K26ESD,
K26ELD, K30ESD, K30ELD: 1 soft breast shield (or 2 for double kits) available in 2 sizes (Small or Large),
1 plastic baby bottle with screw cap (or 2 for double kits), 1 tube (or 2 for double kits).
Kitett® helps you in choosing the right size of breat shield with:
- the Kolorama size ruler to help choose your size
- the KolorYou® application which can be downloaded free of charge from:
2.1. BREASTPUMP WITH AUTOMATIC CONTROL
Rhythm and suction power are automatically controlled by the device.
2.2. IDENTIFICATION
Each breastpump has its own identification code (reference and unit) showing the manufacturing date,
manufacturing order and personal code.
Example: 67 242 HE 03
67: manufacturing year (67: 1950 + 67 = 2017)
242: day of the year
HE: personal code
03: number of order (in a series)
2.3. SYMBOLS
Device type BF Electrical safety class 2 See instructions Manufacturer Dangerous
for use voltage
Caution/Warning Serial number Alternative current Device reference
Keep dry Fragile Keep away Off On European thread
from light
BPA free
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3.
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PR RE EC CA AU UT TI IO ON NS S F FO OR R U US SE E
Keep carefully these instructions for use as this booklet provides necessary information for the good
use of the equipment.
Before connecting the device to the mains, check the values on the device (volts and Hz) and your
distribution network.
The warranty does not cover faulty connections.
Fragile medical device, to be manipulated with care.
Keep this medical device out of the reach of children or animals (potential risks with the tubes and
detachable part of the accessory).
Connect the device to an easily accessible plug, to allow a rapid disconnection from the mains.
The device has to be installed and put into service according to the information supplied with the
attached documents.
I
IM MP PO OR RT TA AN NT T R RE EM MA AR RK KS S: :
Make sure no milk penetrates into the interface bottle or into the pump.
Do not use Expression Kits KOLOR®with a free control breastpump (ref. KV, KL, KLR, KBOX, KBOXR) and
do not connect them to the central vacuum hospital system.
The European version of the KOLOR®breast shield (i.e. with European thread) can only be used
with a corresponding baby bottle (same thread).
Should the pump not work properly, please check that:
The Kolor®breast shield is well screwed on the baby bottle(s) (screw completely),
The cap of interface bottle is correctly fitted,
The tubes are well connected and not pinched.
This medical device is directly connected to the electric power supply, do not use it in bath or under
the shower, do not immerse.
Keep this medical device away from any high heat source.
Store properly the electric cord and the tubes after each use.
Kitett devices are designed to operate at altitudes less than or equal to 3 000 meters.
No special knowledge or training is required to use Kitett devices.
An animal can eat the electric cord. Thoroughly check the state of the equipment before use.
The mains plug is the disconnecting device and must always be accessible.
P
PA AR RT TI IC CU UL LA AR R W WA AR RN NI IN NG GS S: :
Do not open the device when connected to the main (electrical shock hazard).
Should the circuits have to be rinsed, entrust the operation to a maintenance professional (risk of bad
handling).
Watch for the good making of the sessions due to hazard of exceeding the regulation parameters and
modifying the applied depression.
This device is to be used either in health care establishment or at home.
Do not use the device outdoors, near a heat source or near a waterhole (bathtub, sink…).
After use, disconnect the device from the mains.
Make sure the device is not exposed to direct sunlight or excessive heat.
Do not touch the device box for more than 1 second during use.
The tube connecting the collecting bottle to the device can reach the temperature of 43.5 °C. The user
should not touch the tube for more than 10 minutes during device use.
The patient is an intended operator. He can use all functions of the device safely.
If necessary, contact the manufacturer if you need help to set up, use or maintain the medical device,
and to report any unexpected operation or event.

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4. . T TE EC CH HN NI IC CA AL L D DE ES SC CR RI IP PT TI IO ON N A AN ND D
PERFORMANCES
4.1.
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OP PE ER RA AT TI IN NG G C CH HA AR RA AC CT TE ER RI IS ST TI IC CS S
Running mode: continuous.
External protection fuses: T 0,5 A H 250 V.
Electric supply 230V (~230V) 50 Hz or 220 V / 60 Hz on request.
Consumption: 100 VA.
4.2.
K
KF FI IS SI IO O( (V V) )
: combines the suction power adjustment with the rhythm set up
Tubes Double Expression Kit
Interface bottle
Switch
4.3.
L
LI IS ST T O OF F S SP PA AR RE E P PA AR RT TS S A AN ND D A AC CC CE ES SS SO OR RI IE ES S
Accessories
Expression Kits Kolor, Small or Large, single or double pumping, size 21, 24, 26 or 30 mm, ref. K21ES (or
EL), K24ES (or EL), K26ES (or EL), K30ES (or EL), K21ESD (or ELD), K24ESD (or ELD), K26ESD (or ELD),
K30ESD (or ELD)
Autoclavable Expression Kits Kolor, Small or Large, single or double pumping, size 21, 24, 26 or 30 mm,
ref. K21ESH, K24ESH, K26ELH, K30ELH, K21ESDH, K24ESDH, K26ELDH, K30ELDH
Kolor funnel, Small or Large, size 21, 24, 26 or 30 mm, ref. WB21ES (or EL), WB24ES (or EL), WB26ES
(or EL), WB30ES (or EL)
Autoclavable Kolor funnel, Small or Large, size 21, 24, 26 or 30 mm, ref. WB21ESH, WB24ESH,
WB26ELH, WB30ELH
Autoclavable Kolor funnel with silicone tube, Small or Large, size 21, 24, 26 or 30 mm, ref. WB21ESHT,
WB24ESHT, WB26ELHT, WB30ELHT
Autoclavable Kolor kit, Small or Large, with glass baby bottle and silicone tube, single pumping,
ref. K21SHV (or LHV), K24SHV (or LHV), K26SHV (or LHV), K30 SHV (or LHV)
Spare parts
PVC tube, diameter 5x8, 1 m-length, for Expression Kit Kolor, ref. Y1091
Silicone tube, diameter 5x8, 1 m-length, for Expression Kit Kolor autoclavable, ref. TU32
Plastic interface bottle, 30 cc, with 3 nozzles, for double (or single) pumping, ref. W2
Set of 2 100 ml-containers, ref. FIBIBN-E
Soft transport bag for BOX breastpumps, ref. MBOXK
Foam filter, ref. YR36
PERFORMANCES:
Weight: 4 kg
Dimensions: 36 x 25 x 18 cm
Variable suction: -120 to -330 hPa
Can be rinsed
Cycles: 40 to 120 cycles / minute
Sound level: < 52.5 dBA
Device with medium suction and low
flow

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5. . I IN NS ST TR RU UC CT TI IO ON NS S F FO OR R U US SE E
PRACTICAL ADVICE:
Before the first use, for hygiene reason, clean the Expression Kit in soapy hot water and
rinse it with clear water. Disinfect it in boiling water (10 minutes minimum).
Set up of the single expression kit: Set up of the double expression kit (can also be
used as single one):
Screw completely the KITETT Kolor® funnel on the baby bottle.
Connect the suction tube to the inlet hose of the Kolor® Kit and to the interface bottle on the unit.
Connect the unit to the mains. Place the Kolor® funnel on the breast and switch the device on
(position I).
All the milk is collected in the 100 ml (maximum value) feeding bottle(s). In case of wrong handling,
the interface bottle avoids milk penetrating into the pump.
KFISIO(V) model:
The regulation knob allows adjusting the cycle and the suction power. To
stimulate the lactation, set the knob on "stimulation", minimum position, (rapid
cycle, low suction).
After the reflex of ejection, set the knob progressively on position "expression" (slower cycle and higher
suction level) to obtain a good expression according to your own level of comfort.

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AFTER EACH USE:
Expression Kit
Stop the device (switch on O), unplug the electric cord and
store it. Disconnect the Expression Kit from the device, close
the baby bottle with the screw cap and keep it refrigerated or
pour the milk in a container of your choice.
Rinse with cold water the parts directly in contact with breast
milk immediately after use in order to remove milk residues.
Wash carefully the Expression Kit (bottle and Kolor® breast
shield) with soapy hot water. Rinse it with clear water and let
it dry in open air on a paper towel. Interface bottle
Check that no milk has penetrated into the interface bottle or in the tubes.
Wash the interface bottle and the tubes if necessary.
Do not use the milk which has penetrated into the interface bottle or tubes.
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6. . C CL LE EA AN NI IN NG G A AN ND D D DI IS SI IN NF FE EC CT TI IN NG G
Never use ether or solvents, like acetone.
Cleaning with alcohol is possible.
CLEANING OF THE UNIT
After each use, cleaning is limited to external parts, using a non-abrasive sponge soaked with alcohol or
with a disinfecting product recommended by the manufacturer (Anios Surfa'safe Premium).
If liquids or solids were introduced into the device or when the foam filter of the device is wet, it is
necessary to contact your pharmacist or your distributor.
CLEANING OF THE ACCESSORIES
After each use, rinse all parts in contact with milk with cold water. Then wash carefully the Expression Kit
with soapy hot water. Rinse it with clear water and let it dry in open air on a paper towel.
The Expression Kit can also be washed in dishwasher.
ACCESSORIES DISINFECTING
Dismantling and disinfecting instructions are indicated on the box.
The Expression Kit can be disinfected in boiling water (10 minutes minimum), in a baby bottle steam
sterilizer*, (EXCEPT tubing which should briefly be dipped in boiling water and then thoroughly dried).
*Refer to the manufacturer's instructions and do not exceed 1 000 W.
The autoclavable Expression kit (autoclavable Kolor funnel, bottle and silicone tube) can be autoclaved.
Note: During disinfecting in boiling water, the tube colour may change but it will not alter good
operating.

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Expression Kit Kolor® for personal use: for hygiene reason, a new complete Expression Kit Kolor® is sold
for each mother.
If case of hard water, 2 or 3 drops of white vinegar can be added during disinfecting in boiling water to
avoid whitish deposits.
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7. . F FA AI IL LU UR RE ES S R RE EM ME ED DI IE ES S A AN ND D W WA AR RR RA AN NT TY Y
1st case: no operating noise can be heard from the pump
Check whether:
The unit is well connected to the mains.
The switch is on the operating position.
Voltage and frequency meet the one of the unit (volts-Hz~).
The wall socket is providing electric current (try with another electric device).
2nd case: no suction at the Expression Kit
Check whether:
The funnel is completely screwed;
The tubes are correctly connected and not pinched.
3rd case: the unit stops suddenly
(mains cut or suction alternating defect)
Disconnect the tube coming from the interface bottle.
In case of alternating stop, contact your supplier.
IN CASE OF ANY OTHER TROUBLE, CONTACT YOUR SUPPLIER
On request, the electrical diagram and the exploded view of the pump are at your disposal.
Each unit has its own identification number.
CAUTION:
In all cases:
WARNING: Always disconnect the unit from the mains before opening it.
WARNING: Only an approved customer service is authorized to repair the device.
WARNING: Modification forbidden.
WARNING: Only use the accessories supplied and mentioned in the instructions for use.
WARNING: Do not undertake service or maintenance operations while the device is in use.
WARRANTY:
The breast pump is warranted 3 years, parts and labour, against any manufacturing defect, except case
of misuse.
For after sales service under warranty, please contact your distributor.
A technical description is available on request.

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Keep the specific packaging and foam set for sending back the device.
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8. . W WA AS ST TE E D DI IS SP PO OS SA AL L
Disposable: household waste respect the regulation in force.
Electric device: respect the legal obligations related to the waste of electric and electronic
equipment.
The device must be given in a special waste centre. Do not leave it in the nature or with domestic
waste in accordance with the EEC standard 2002/96/CE.
Product on the market since August the 13th 2005.
So you contribute to the human health and environmental protection.
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BR RE EA AS ST TF FE EE ED DI IN NG G I IS S N NA AT TU UR RA AL L. .
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It t i is s i im mp po or rt ta an nt t f fo or r a a h he ea al lt th hy y g gr ro ow wt th h o of f y yo ou ur r b ba ab by y. .
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If f y yo ou u h ha av ve e t to oo o m mu uc ch h m mi il lk k, , i it t c ca an n b be en ne ef fi it t t to o a an no ot th he er r c ch hi il ld d. .
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Pl le ea as se e c co on nt ta ac ct t t th he e c cl lo os se es st t m mi il lk k b ba an nk k f fr ro om m y yo ou ur r h ho om me e. .