2.1. Breastpump with variable control 2.2. Identification 2.3. Symbols used

Transcription

1 BREAST FEEDING INSTRUCTIONS FOR USE ELECTRIC BREASTPUMP Model: KFISIOP 0459 (2003) Directive 93/42/CEE - Medical device Class IIa All KITETT breastpump accessories are BPA free DIFFUSION TECHNIQUE FRANCAISE 19 rue de la Presse CS SAINT-ETIENNE Cedex 1 France Tel Fax dtf@dtf.fr - Création MJ/CC/MPS Ind.8 LCM/MPS K.NU.EN

2 CONTENTS 1. CLASSIFICATION AND ELECTROMAGNETIC COMPATIBILITY 2. PRESENTATION AND INDICATIONS 2.1. Breastpump with variable control 2.2. Identification 2.3. Symbols used 3. PRECAUTIONS FOR USE 4. TECHNICAL DESCRIPTION and PERFORMANCES 4.1. Operating characteristics 4.2. KFISIO P 4.3. List of accessories and spare parts 4.4. Replacement of fuses 5. INSTRUCTIONS FOR USE 6. CLEANING AND STERILIZATION 7. FAILURES REMEDIES AND WARRANTY 8. WASTE DISPOSAL 2

3 1. CLASSIFICATION Medical device class IIa Medical device class 2 (electrical safety). Type BF Level of protection IP 30: Protected against ingress of solid foreign objects with a diameter 2.5 mm Not protected against vertical water drops 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 + 70 C Room temperature - 25 C 93 % Relative humidity 15 % 1060 hpa Atmospheric pressure 700 hpa Applied part: Expression Kit Kolor Nota: the CE declaration is available on request. OPERATING + 40 C + 5 C 93 % 15 % 1060 hpa 700 hpa ELECTROMAGNETIC SENSIBILITY Medical electrical equipment requires special precautions regarding EMC and shall be installed and put into service according to the EMC information supplied in this booklet. WARNING: it is advisable that the device is not used next to other devices or not pilled on the latter. WARNING: the use of cables or accessories other than those specified in the instructions for use can negatively affect the EMC performances. Compliance with EMC standards does not mean a device has total immunity. Few devices (cellular phones, pagers, etc.) can interrupt operation if their use is made near medical equipment. Guidance and manufacturer's declaration electromagnetic emissions The KITETT breastpumps are intended for use in the electromagnetic environment specified below. The customer or the user of the KITETT breastpumps should assure that they are used in such an environment. Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 RF emissions - CISPR 11 Harmonic emissions IEC Voltage fluctuations / flicker emissions IEC Group 1 Class B Class A Complies The KITETT breastpumps use RF energy only for their internal function. Therefore, their RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The KITETT breastpumps are 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. 3

4 Guidance and manufacturer's declaration electromagnetic immunity The KITETT breastpumps are intended for use in the electromagnetic environment specified below. The customer or the user of the KITETT breastpumps should assure that they are used in such an environment. IEC Immunity test Compliance level Electromagnetic environment - guidance test level Electrostatic discharge (ESD) IEC Electrical fast transient / burst IEC Surge IEC Voltage dips, short interruptions and voltage variations on power supply input lines IEC ± 6 kv contact ± 8 kv air ± 2 kv for power supply lines ± 1 kv for input/output lines ± 1 kv line(s) to line(s) ± 2 kv line(s) to earth <5 % U T (>95 % dip in U T) for 0,5 cycle 40 % U T (60 % dip in U T) for 5 cycles 70 % U T (30 % dip in U T) for 25 cycles <5 % U T (>95 % dip in U T) for 5 s ± 6 kv ± 8 kv ± 2 kv ± 1 kv ± 1 kv line(s) to line(s) ± 2 kv line(s) to earth <5 % U T (>95 % dip in U T) for 0,5 cycle 40 % U T (60 % dip in U T) for 5 cycles 70 % U T (30 % dip in U T) for 25 cycles <5 % U T (>95 % dip in U T) for 5 s Power frequency (50/60 Hz) magnetic field IEC A/m 3 A/m NOTE: U T is the a.c. mains voltage prior to application of the test level. Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the KITETT breastpumps requires continued operation during power mains interruptions, it is recommended that the KITETT breastpumps be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Guidance and manufacturer's declaration electromagnetic immunity The KITETT breastpumps are intended for use in the electromagnetic environment specified below. The customer or the user of the KITETT breastpumps should assure that they are used in such an environment. Immunity test IEC test level Compliance level Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the KITETT breastpumps, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Conducted RF IEC Radiated RF IEC Vrms 150 khz to 80 MHz 3 V/m 80 MHz to 2,5 GHz 3 V 3 V/m Recommended separation distance d = 1,16 P d = 1,16 P 80 MHz to 800 MHz d = 2,33 P 800 MHz to 2,5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the KITETT breastpumps are used exceeds the applicable RF compliance level above, the KITETT breastpumps should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the KITETT breastpumps. b Over the frequency range 150 khz to 80 MHz, field strengths should be less than 3 V/m. 4

5 Recommended separation distances between portable and mobile RF communications equipment and the KITETT breastpumps The KITETT breastpumps are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the KITETT breastpumps can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the KITETT breastpumps as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter Rated maximum output power of m transmitter 150 khz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz W d= 1,16 P d = 1,16 P d = 2,33 P 0,01 0,116 0,116 0,233 0,1 0,366 0,366 0, ,16 1,16 2, ,66 3,66 7, ,6 11,6 23,3 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W), according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 2. PRESENTATION AND INDICATIONS Your KITETT electric breastpump allows an easy collection of the mother's milk. INDICATIONS: This KITETT electric breastpump is also designed for medical purpose, as engorged, painful or swollen breast. It is supplied either with: a single 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). Tube connection Comfort breast shield with integrated gasket Bottle Composition of KITETT accessories (BPA free): K21ES, K21EL, 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: 5

6 2.1. BREASTPUMP with VARIABLE control KFISIOP Rhythm and suction power are automatically controlled by the device IDENTIFICATION Each breastpump has its own identification code (reference and unit) showing the manufacturing date, manufacturing order and personal code. Example: HE 03 65: manufacturing year (65: = 2015) 140: day of the year HE: personal code 03: number of order (in a series) Each expression kit has a lot identification with the manufacturing date and the code of the operator who produced it. Ex.: : operator code; 5: year (2015); 42: manufacturing week 2.3. SYMBOLS USED 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 O I 3. PRECAUTIONS FOR USE 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. 6

7 IMPORTANT REMARKS: 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) 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. can only be used 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 device is designed to operate at altitudes less than or equal to meters. No special knowledge or training is required to use Kitett device. An animal can eat the electric cord. Thoroughly check the state of the equipment before use. PARTICULAR WARNINGS: 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 more than 1 minute during its use. 4. TECHNICAL DESCRIPTION AND PERFORMANCES 4.1. OPERATING CHARACTERISTICS 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. 7

8 4.2. KFISIO(P) combines independent suction power adjustment and rhythm set up PERFORMANCES: Double Expression Kit Interface bottle Weight: 4 kg Dimensions: 36 x 25 x 18 cm Can be rinsed Variable suction: -50 to -350 hpa Cycles: 40 to 125 cycles / minute Sound level: < 47 dba Device with medium suction and low flow Main switch Suction strength Suction cycle Accessories 4.3. LIST OF SPARE PARTS AND 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), WBE26S (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 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 ml-containers, ref. FIBIBN-E Glass baby bottle 125 ml, ref. ZV Soft transport bag for BOX breastpumps, ref. MBOXK Fuses T 0.5A H 250V (according to IEC ) Foam filter, ref. R36 8

9 4.4. REPLACEMENT OF FUSES Switch the device off, unplug the power cord from the wall socket. Unscrew the top of the fuse holders by ¼ turn. Check them and change them if necessary, respecting their caliber and type. If the caliber of the fuses is too high, there is a risk of device's overheating. 5. INSTRUCTIONS FOR USE PRACTICAL ADVICE: Before the first use, for hygiene reason, clean the Expression Kit in soapy hot water and rinse it with clear water. Sterilize 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 (indicative value) feeding bottle(s). In case of wrong handling, the interface bottle avoids milk penetrating into the pump. KFISIOP: - The "cycles" control knob allows adjusting suction cycles from 40 to 120 cycles / minute. - The "suction" control knob graduated from 1 to 9 allows adjusting the suction from minimum to maximum. Advice for use 1/ Stimulation Start with a 2 minutes phase by adjusting: - "suction" control to 1 (lowest suction), - "cycles" control to 120 (quick cycles). According to your own comfort level, you may adapt these settings by increasing the suction force and/or decreasing the cycle. 9

10 2/ Milk expression When the stimulation phase is over (milk flowing from the nipple): - select a slower cycle by turning the "cycles" control clockwise, - and increase the suction control according to your own comfort level. If you experience any discomfort, you should adjust the suction level accordingly. 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. Check that no milk has penetrated into the interface bottle or in the tubes. Wash the interface bottle and tubes if necessary. Do not use the milk which has penetrated into the interface bottle or tubes. Interface bottle 6. CLEANING AND STERILIZATION Never use ether or solvents, like acetone. Cleaning with alcohol is possible. CLEANING OF THE UNIT 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 METHOD Remove the plastic cap from the evacuation nozzle and the foam filter underneath the device. Place the evacuation nozzle over a sink. Wash the internal circuit by making the device suck up hot water (40-60 C) with a kit tube placed in a water container (about 0.5 l) until it comes out clear through the evacuation nozzle. Remove the tube from the water container and let the device run during 20 minutes after evacuating all water to dry out the internal circuit. 10

11 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 STERILIZATION Dismantling and sterilization instructions are indicated on the box. The Expression Kit can be sterilized 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 W. The autoclavable Expression kit (autoclavable Kolor funnel, bottle and silicone tube) can be autoclaved. Nota: During the sterilization in boiling water, the tube colour may change but it will not alter good operating. Expression Kit Kolor for personal use: for hygiene reason, a new complete Expression Kit Kolor is sold for each mother. In case of hard water, 2 or 3 drops of white vinegar can be added during sterilization in boiling water to avoid whitish deposits. 7. FAILURES REMEDIES AND WARRANTY 1 st 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 fuse(s) of the pump is (are) not burnt out. The wall socket is providing electric current (try with another electric device). 2 nd case: no suction at the Expression Kit Check whether: The funnel is completely screwed; The tubes are correctly connected and not pinched. 11

12 3 rd 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. 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 documentation is available on request. Keep the specific packaging and foam set for sending back the device. 8. WASTE DISPOSAL 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 13 th So you contribute to the human health and environmental protection. BREASTFEEDING IS NATURAL. It is important for a healthy growth of your baby. If you have too much milk, it can benefit to another child. Please contact the closest milk bank from your home. 12