Carum - Breast pump Ardo - Free user manual and instructions

USER MANUAL Carum Ardo

i.en en 17 Ardo medical AG Congratulations on your purchase, and thank you for choosing the gentle Carum breastpump from ARDO. In these instructions you will find important and useful details which will make your Carum experience even more rewarding. When using electrical devices it is very important to observe the following safety regulations. Please take the time carefully to read the user manual before using the Carum for the first time. Please start with Section 4 - (Start-up / Operation) – before you plug your Carum into the mains power supply, or connect to the car battery (optional cable) or start battery operation mode (optional).

4.3.2. Regulation of the vacuum and display 22

4.3.3. Cycle regulation and display 22

skipping stimulation mode 23

5.1. Adjustingthevacuum(intensityofsuction) 24 5.2. Regulate the cycle 24 5.3. Encouraging the Let down reflex 24 5.4. Express efficiently 24 5.5. Increase the quantity of milk 24

11.1. Transport and storage conditions 28 11.2. Disposal 28

Carum is an electrically-operated, safe and reliable breastpump for personal use. Carum is constructed and assembled in accordance with CE guidelines, and in compliance with Security Standards EN 60601-1, EN 60601-1-2, EN ISO 10079-1, EN 60601-1-4 and EN 60601-1-6 and EN 60601-1-11 . For your safety, to avoid damagetotheunitandtoavoidriskofelectricshock,injuryorre,pleaseobservethefollowingsafetyregulations. Safety Regulations

• Afteruse,disconnectCarumfromthemains.

• Intheeventofanaccidentalsplash,ortheunitfallingintowater-IMMEDIATELYdisconnectitfromthemains. Do not touch the unit until it has been disconnected.

• Carumisnotwater-proof.Thereforetheunitmustneverbeimmersedinwaterorotheruids,norusedor stored in places where it might fall into the water. Do not use while in the bath or while taking a shower.

• Iftheoperatingtimeofthebatterydeclinesfromfullychargedtolessthanonehour(ofcharge),thebattery should be changed as soon as possible, to ensure safe operation of the Carum when on battery power. See

Section 8: Maintenance / Care / Cleaning.

• IftheCarummustbealteredorchangedtoensuresafecontinueduse,theappropriatestudiesandtesting must be carried out.

The Carum Pump System consists of the breast pump and a PumpSet (single or double pumpset). The Carum breast pump is a quiet, user-friendly double piston pump for hospital use and for rental use. The unit is equipped with a robust plastic housing (Quality: VO) and a simplified, logically organised keyboard with a LCD display readout. The energy-saving electrical equipment is designed for mains- and for car battery-operation, or for (optional) battery use. Thesophisticatedcontrolsalloweachmothertoenjoyacomfortableandecientpumpingexperience(plusa testedsucklingcurve)thankstotheexiblesystemforadjustingvacuumandcycles. 2.1. Suckling Curve The suckling curve is characteristically stable over the entire vacuum and cycle area and corresponds closely to your baby’s suckling behaviour. Therefore the breast tissue is not additionally stressed by pumping. Stimulation mode Exchange Stimulation-Expression Expression mode

3. APPLICATION FOR USE

The Carum breastpump system is intended for the expression of breast milk, for the collection and storage of mother’s milk in the event of nursing problems e.g. galactostasis, sore nipples, illness or in the absence of either mother or baby e.g. premature infants. Carum can be used as both a single pump and as a double pump. The unit is intended for indoor use only. 3.1. Indications Carum •Toalleviateengorgement.

• Toincreaseandmaintaintheabilitytobreastfeed.

• Ensurethesupplyofbreastmilkshouldmotherandbabybeseparated. Carum can be used as both a single pump and as a double pump. 3.2. Contra- indications None known: when the unit is used for the correct purpose.en en 20 Ardo medical AG

4. STARTUP / OPERATION

4.1. Icons Read the manual Important information “ON / OFF“ switch Sucklestrength/Adjustthevacuum(V) Change the cycles level / number (C) Switch stimulation mode / express mode Backlight change (light / dark) Time measurement (on / stop / off ) Unit with the applied part BF Cleaning Single pumpset / Double pumpset (applied part)

Warning: General risk points – check the Instruction Manual

Compliance with general guidelines: MDD 93 / 42 EWG and MDD 2009 Manufacturer The unit is compliant with the stipulations of the WEEE 2002 / 96 / EG guidelines Mains cable Device of protection category II IP21 IP 21 drip proof Li-Ion Contains a lithium ion battery Express mode Stimulation mode Device is recyclableen en 21 Ardo medical AG 4.2. Installation

4.2.1. Electrical connection

• Mainsoperation:Insertmainscable(A)intotheCarummains(B)input socket (Fig.1) and connect the local power plug to the mains power supply.

• Batteryoperation:Beforeusingthebatteryforthersttime,connect the unit to the mains power supply for 6 hours.

4.2.2. Connecting the PumpSet

Use of the PumpSet is detailed in the separate user manual: “ARDO PumpSet“. The PumpSet is an applied part of the pump.

• Thesecondopeningofthetubeconnector(E) remains closed – by single and double pumping.

4.2.3. Installing the bottle holder

The bottle holder is used for short-term storage of the PumpSets. The bottle holder is designed to protect against accidental spilling of milk. The bottle holder can be used free-standing or be plugged into the back of the Carum

4.2.4. Installing the EasyFreeze holder

The easy freeze holder is used for short-term hang up of the PumpSet with bag. The EasyFreeze holder is designed to protect against accidental spilling of milk. The EasyFreeze holder can be plugged onto the back of the Carum instead of the bottle holder.

Een en 22 Ardo medical AG 4.3. Operation Vacuumandcyclescanbeadjustedindependentlyofeachother.Select theadjustmentwhichisthemostcomfortableforyou.

4.3.1. Switch on / switch off

Switch on the unit by pressing the “ON / OFF” button once. A ‘welcome’ page will be displayed. When it is switched on, the breast pump is in stimulation mode (orange display). Medium vacuum and cycle level. To turn the unit off, press the “ON / OFF” button once again. The “ON / OFF” function is the same for battery operation, mains power supply or 12vDC power supply (car battery operation). Display mode: The operation mode is shown on the illuminated LCD display. The display turns off when the unit is switched off.

4.3.2. Regulation of the vacuum and display

Thevacuum(suctionstrength)canbeadjusted,one level at a time, by repeatedly pressing, or by holding down the vacuum button (to the left side of the key pad). The vacuum strength can be individually regulated in both stimulation mode and expression mode. Pressing the ‘up’ arrow increases the vacuum, pressing the ‘down’ arrow reduces the vacuum. The vacuum strength is displayed on the bar chart to the left.

4.3.3. Cycle regulation and display

Thecycles(frequency)canbeadjusted,one level at a time, by repeatedly pressing, or by holding down the cycle button (to the right side of the key pad). The cycle can be individually regulated in both stimulation mode and expression mode. Pressing the ‘up’ arrow increases the cycles level, pressing the ‘down’ arrow reduces the cycles level. The cycles level is displayed on the bar chart to the right.en en 23 Ardo medical AG

4.3.4. Switch stimulation mode / expression mode

To change the stimulation mode display screen (orange display) to the expressmodedisplayscreen(greendisplay),pressthe‘Mode’buttonjust to the right of the “ON / OFF” button. The change can be made at any time by pressing the ‘Mode’ button. If the Carum is in stimulation mode and the ‘Mode’ button is not pressed, the unit will automatically change to express mode after 2 minutes. Press the ‘Mode’ key to return to stimulation mode. When the mode changes, the background colour of the LCD screen changes accordingly. In addition, the symbol relevant to stimulation or expression mode will be highlighted on the LCD display. Background colour in stimulation mode is orange. Background colour in expression mode is green. In each separate mode of operation, vacuum strength and cycles level can beindividuallyadjusted. When changing from stimulation mode to expression mode, the vacuum strength will automatically be set to 30mbar, and the cycles level to 45 cycles, from the previously set values. When changing from express mode to stimulation mode, the vacuum strength will be set to 60mbar, and the cycles level to 90 cycles. These values also apply when the unit is switched on.

4.3.5. Using express mode, skipping stimulation mode (“Sensitive Programme”)

If the ‘mode’ button is pressed within 2 seconds of switching on the Carum, stimulation mode is skipped. Express mode starts with an especially mild, gentle and low level vacuum of 30mbar and a cycles level of 30 cycles.

4.3.6. Timing / Time Button

Timing starts automatically when the Carum is switched on. To stop timing, press the ‘time’ button. Timing will remain de-activated until re-started by pressing the ‘time’ button again, or until the unit is turned off. The timer will be reset to 00:00 when the ‘time’ button is pressed for a second time. Press the ‘time’ button again to restart the timer. The timer can be switched on and off in either stimulation or express mode.

Using the Carum in a darkened room can be made more comfortable by dimming the intensity of the LCD. To reduce the intensity of the backlighting, press the ‘light’ button (to the left of the LDC) once. The dim function can be turned on and off as required.en en 24 Ardo medical AG

5.1. Adjusting the vacuum (intensity of suction) Expressing milk should never be painful.

• Setthevacuumintensityatthehighestlevelwhichiscomfortableforyou.

• Intheeventthatthemilkisnotreleased,trymassagingthebreast–thiscanbereallyeective. Regulate the vacuum by touching the arrow keys.

• Intensifythevacuum,untilyoufeelaveryslightdiscomfort,andthenreducetheintensityofthevacuumuntil pumping is comfortable.

• Intheeventofsorenipplesorpainfulbreasts,skipthestimulationmode.TheCarumwillthenstartinexpress mode with an especially mild, gentle and low level vacuum.

• Itisrecommendedthat,inpump-orstimulationmode,youadjustthesuctionstrengtheachtimeto suit your personal comfort level. This is because the vacuum level generated is sensitive to prevailing atmospheric pressure. 5.2. Regulate the cycle

• Whenbabiesstarttobreastfeed,theysucklewithrapidsuckingmotionsandlowsuction–thiscausesthemilk toreleasebystimulatingthemilkejectionreex. For this reason, the Carum will automatically start in stimulation mode, i.e. with a higher cycles level and a lower vacuum strength, mimicking the baby’s natural behaviour.

• Selectstimulationmode,choosethelevelofvacuumwhichfeelsmostcomfortable.

• Whenthemilkbeginstoow,thebaby’ssuckingpatternchanges.Thebabysucksmoreslowly,butmore strongly. Change to express mode, and strengthen the vacuum and raise the cycles level by pressing the arrow until a comfortable pumping experience is achieved.

• Ifthemilkowfalters,returntostimulationmodetopromptrenewedmilkow. 5.3. Encouraging the Let down reex Themilkejectionreexmayoccurlaterwhenpumpingthanwhenbreastfeeding.Thefollowingmeasuresmay be helpful.

• Relaxandthinkaboutyourbaby.

• Lookatapictureofyourbaby.

• Massagingthebreastwhileusingthebreastpumpcanboostmilkproduction,andpromotebettermilkow. 5.5. Increase the quantity of milk

• Fortherst10minutes,oruntilnomoremilkisowing,useadoublepumpi.e.expressfrombothbreastsat once. Afterwards, switch to a single pump. Express from each breast for five minutes while massaging gently.en en 25 Ardo medical AG

Identifiable errors or service / maintenance schedules are represented on the LCD by a warning triangle. Switch the unit off, and then on again. If the error message comes up again, return the unit to the supplier. The unit must be repaired by trained service personnel, or by the manufacturer. Error: the unit does not work on battery power i.e. the pump does not operate. Solution: Connect the unit to the mains to recharge the battery. The battery charging time is ca. 4 hrs. Advice: The unit may be used while the battery is being charged, but this will extend the charging time. 7.1. Further possible errors when using the unit

• Weakorabsentvacuum Disconnect the PumpSet from the unit. Partly close the connector opening with a finger to test the suction. If suction is de-tectable, then the pump is working. Test the PumpSet in accordance with the separate instructions, (only use the original ARDO PumpSet)

• Thepumpisnotworking/nodataontheLCDdisplay Check the mains supply; if the unit still does not work, it is defective Should any of these errors occur, and be confirmed, return the unit to the supplier immediately. The unit must be repaired by trained service personnel or by the manufacturer.

8. MAINTENANCE / CARE / CLEANING

The silicone pot integrated into the PumpSet constitutes a total barrier, and ensures that neither breast milk nor pathogenic agents can get into the pump unit. The unit is maintenance-free; care of the unit, and its accessories, is limited to inspection and cleaning. The Carum breast pump can be repaired, but only by trained service personnel or by the manufacturer. For this reason, only the bottle holder, the EasyFreeze holder, the connector cable, and the car charging cable, are available for order as spare parts. See Section: Accessories / Spare Parts.en en 26 Ardo medical AG 8.1. Visual inspection before switch-on

• Istheaccessorycorrectlyattached? Ignoring these checks, or the cleaning instructions, may lead to risk of infection, electric-shock or damage to the unit. 8.2. Cleaning / disinfection

• Carumbreastmilkpump: Important: unplug the unit from the mains connection before cleaning.

• TheCarumisnotwaterproof.ItconformstoenclosureIP(IngressProtection)ratingIP20. Cleaning at home: As needed, wipe with a damp cloth, commercial detergent may be used. Cleaning in the hospital: Disinfect by wiping with a non-phenol based disinfectant. Do not put the unit into the dish-washer or into a washing-up bowl. It is not possible to clean the pump or the power unit. Attempting to do so may cause the unit to malfunction or to become contaminated – requiring suitable disposal. (See section 11: Transport / Storage / Disposal).

• Visualinspectionofthepumpforcleanliness After every renting

• Visualinspectionofthepumpforcompleteness After every renting

• Visualinspectionofthepumpforcleanliness Before every use

The Carum is guaranteed for 3 years from the date of purchase. The purchase invoice serves as proof of guarantee. General terms and conditions This unit is covered by the Ardo medical AG warranty in respect of materials and manufacturing defects. The guarantee starts from the date of purchase. Defective materials will be replaced free-of-charge, during the life of the Guarantee, provided that the Guarantee has not been voided by unauthorised use or access to the unit. To ensure guarantee cover, and the flawless functioning of the unit, the instructions in the User Manual must be followed and only Ardo medical AG accessories used. The guarantee is void if the unit has been opened.en en 27 Ardo medical AG

10. TECHNICAL INFORMATION

10.1. Version Carum with Euro mains cable Art. No. 63.00.71 Carum battery with Euro mains cable Art. No. 63.00.75 Carum with UK mains cable Art. No. 63.00.72 Carum battery with UK mains cable Art. No. 63.00.76 Carum with UL mains cable Art. No. 63.00.73 Carum battery with UL mains cable Art. No. 63.00.77 10.2. Technical data Pump dimensions L x B x H = 302 x 240 x 180 mm Power cable length Length 3 m Pump weight 3 kg Weight with battery 3.7 kg Input voltage 100 – 230 VAC + / -10% Frequency 50 – 60Hz DC Input 12 VDC Lifetime (excluding parts subjecttowearandtear) 10 years Operating temperatures +5 – +40 °C Relative humidity 10 – 93% Protection level BF Air pressure 700 – 1060 hPa Protection Category Double Insulated Category II Classification in accordance with MDD93 / 42 Category 2a Cycle and vacuum levels Vacuum range in stimulation mode 30 – 150 mbar 22 – 98 mmHg 3 – 13 kPa Cycle range in stimulation mode 72 – 120 / min. Vacuum range in expression mode 30 – 330 mbar 22 – 250 mmHg 3 – 33 kPa Cycle range in expression mode 30 – 60 / min. Permitted tolerance of the vacuum strength + / - 5% Permitted tolerance of the cycles + / - 3 cycles The vacuum level generated is sensitive to prevailing atmospheric pressure. The higher the prevailing atmospheric pressure, the more intense the generated vacuum – and vice versa. The vacuum values (including tolerances) specified in the user manual are based on an atmospheric pressure of 880hPa. 10.3. Compliance In accordance with guidelines: MDD 93 / 42 CEE of 14.7.1993, and 2010, in respect of medical products and 2010. 2007 / 47 / CE, 2006 / 42 / CE, EN 60601-1, EN60601-1-2, EN ISO 10079-1, EN 60601-1-4, EN 60601-1-6, EN 60601-1-11

3. APPLICATIONS / INDICATIONS 32

12.1. Homologations CEM 185fr fr 31 Ardo medical AG

3. APPLICATIONS / INDICATIONS

4.3.6.Tijdmeting/stopwatch 62

2. PRODUCTBESCHRIJVING

INNEHÅLLSFÖRTECKNING