CARUM Instructions for Use V01 Aug 2018

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1. Product location in the container i

a Carum breastpump b Connector openings for the pumpset c Control panel with LCD screen d Connector for power cord e Bottle holder f Easy Freeze holder (holds freezer bag) g Power cord h Carum container i Address field j Pumpset (not included in the delivery contents) k Instructions for use

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a CARUM

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Instructions for use | Gebrauchsanweisung | Mode d'emploi | Istruzioni per l’uso | Instrucciones de uso | Instruções de utilização | Gebruiksaanwijzing | Bruksanvisning | Käyttöohjeet | Instrukcja użycia | Οδηγίες χρήσης | Kullanım kılavuzu | ‫ | ﺗﻌﻠﻴامت اﻻﺳﺘﺨﺪام‬使用说明

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2. Intended Use 2.1. Indications The Carum breastpump is intended for use by breastfeeding women to express and collect their milk. It can be used as a single pump or as a double pump. The device is only intended for use indoors and is meant for several users. 2.2. Contraindications The Carum must not be used during pregnancy because expressing milk can trigger contractions.

3. Safety Instructions

Important safety information Please read the instructions for use carefully before using the pump for the first time. Keep these instructions for use in a safe place for later reference. The Carum is an electric breastpump for use in hospitals and for hire. For your health and safety and to prevent damage to the device, the following safety rules must be followed. Safety rules DANGER: To avoid a fatal electric shock • Only use the original power cord supplied by Ardo. • Never use a faulty power cord. • Never position an electrical device where it may fall into liquid. • Never touch an electrical device that has fallen into liquid or is wet. Disconnect the device immediately from the power supply. • Never use a device that has fallen into liquid or is wet but send the device to a service point or the manufacturer for inspection. • Never use the Carum when taking a bath or showering. • Never open the Carum! There is the risk of an electric shock.

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en WARNING: To avoid damage, electric shock, fire or injury • The Carum is not intended for use outdoors. • Never use the Carum if it is not functioning correctly, has been dropped, or is faulty. • When using an electrical device, pay particular attention to children or people of impaired intelligence who are nearby; electrical devices are not toys. • You must always connect the power cord to the Carum first and then plug it into the power socket. • Never leave the Carum unattended when it is connected to mains power supply. • Disconnect the Carum from the mains power supply after use. • The device is only disconnected when the power plug is removed from the power socket. • Position the Carum so that it can be easily disconnected from the mains power supply. • Keep the Carum as well as the power cord and all accessory parts away from hot surfaces. • Only use the Carum for the purposes listed in the section "Intended use". • Only use original Ardo pumpsets and original Ardo parts. • Do not insert any objects into openings or tubes on the Carum and do not allow any objects to fall into openings or tubes. • Do not use the Carum in an environment in which oxygen is administered or sprays are used. • The Carum must not be modified without the permission of the manufacturer. WARNING: To avoid damaging your health or injuries • Check the Carum and the associated parts before every use. • Never use the Carum when you are sleeping or feeling tired. • If expressing milk is uncomfortable or painful, stop pumping and ask for advice from the responsible qualified personnel. • Do not use the Carum if you are pregnant because expressing milk can trigger contractions. • Follow the instructions in the relevant section "Cleaning / Inspection / Maintenance" for cleaning. Car adapter • The Carum and the Carum Battery are not intended for use outdoors even with the car adapter. • Only use the original electrically protected car battery cable supplied by Ardo. • Ensure that your car has a 12 V DC connection. • Do not express milk while driving, even as a passenger. This may lead to an accident. • Disconnect the Carum from the electrical system after use or after recharging.

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4. Product Description • • • • •

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The Carum electric breastpump is intended for use in hospitals and for hire. The Carum can be used for single pumping and double pumping (expressing milk from both breasts at the same time). The cycles and the vacuum can be adjusted as required and independently of each other. The color screen provides visual orientation and the integrated stopwatch indicates the duration of pumping. To mimic the natural suckling behavior of the baby, milk can be expressed in two phases using the Carum: the stimulation mode and the actual expression mode. The stimulation mode starts the milk flow and the subsequent expression mode enables efficient pumping of the milk. The Carum starts with the stimulation mode and changes independently to the expression mode after two minutes. If required, you can switch to the expression mode early by pressing the mode button during this two minute period. To stimulate the milk flow again while expressing, you can easily change back to the stimulation mode at any time by pressing the mode button. The "Sensitive Programme" can be used if your nipples are sore to gently express milk with the minimum starting vacuum and minimum cycle. Ardo pumpsets create a 100% hygienic barrier between the breast milk and the breastpump. This closed system ensures that breast milk cannot end up in the tube of the pumpset or in the breastpump itself. The Carum Battery contains a rechargeable battery unit. The Carum and the Carum Battery can be operated with mains power or with an optional car cable in the car.

Carum Battery – the Carum with integrated rechargeable battery unit The Carum Battery enables milk to be expressed anywhere and allows you to express milk beside the crib of an ill or newborn baby. Being close to your baby helps with the let-down reflex. • • • •

The running time with a fully charged battery unit is about four hours (at max. vacuum and max. cycle). Recharging a flat battery unit takes about two hours. If the running time with a fully charged battery unit drops to less than one hour, the battery unit needs to be replaced at the closest service point or the manufacturer to restore optimal operation. If the device is connected to the mains power, the battery unit is recharged while milk is being expressed. The recharging time is prolonged in this case. If the Carum is connected to the electrical system of a vehicle via the car cable, the battery unit is not recharged while milk is being expressed. After switching the device off, the battery unit is charged via the electrical system of the car.

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5. Start-up / Operation 5.1. Key Follow the instructions for use On / off button (stand-by button) Vacuum button (to change the vacuum) Cycle button (to change the cycle) Mode button (to switch between stimulation / expression / "Sensitive Programme") Dimmer button Button for time measurement Expression mode Stimulation mode Device with applied part BF 0123

Conformity according to MDD 93 / 42 / EEC Manufacturer The device is subject to the requirements of the WEEE Directive Power supply unit Alternating current Device is protection class II

IP21

Drip proof

Li-Ion

Contains a lithium ion rechargeable battery unit Device can be recycled

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en 5.2. Start-up 5.2.1. Electrical connection • Insert the power cord (a) into the Carum power connection (b) and connect to the power socket. b

a 5.2.2. Connecting the pumpset (applied part) The use of the pumpset is described in the separate operating instructions for the "Ardo Pumpset". • Pumping with single pumpset: Insert the tube connector (c) into one of the two connection openings on the pump.

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Pumping with double pumpset: Insert both tube connectors (d) into the connection openings of the pump.

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The second opening (e) of the tube connector must always be closed for both single and double pumping.

e 5.2.3. Attaching the bottle holder The bottle holder (f) can be hung onto the back of the Carum or freely positioned.

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5.2.4. Attaching the Easy Freeze holder The Easy Freeze holder (g) is used to hang a freezer bag or breast milk g bottle on the pumpset. It can be hung onto the back in place of a bottle holder.

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en 5.3. Operation Vacuum and cycles can be adjusted independently of one another. Select the setting that is most comfortable for you. a b c d e f g h i j k l m n

On / off button (stand-by button) Vacuum button (to change the vacuum) Vacuum indicator Dimmer button Dimmer information Time information Stopwatch information Button for time measurement Cycle indicator Cycle button (to change the cycle) Mode button (to switch between stimulation / expression / "Sensitive Programme") Expression mode Stimulation mode Information ribbon (n = e + f + g)

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Cycles

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5.3.2. Stimulation mode – Orange background When it is switched on, the Carum starts automatically in the stimulation mode (orange background) with a rapid cycle and a slight vacuum. This mode stimulates the let-down reflex. The automatic setting imitates the natural behavior of the baby. At the start of breastfeeding, babies suckle with rapid sucking movements and low suction strength which triggers the flow of breast milk. The stimulation mode lasts for two minutes and then switches automatically to the expression mode. The vacuum and the cycles can be increased or reduced by pressing the buttons repeatedly or holding them down. The selected settings are shown using bars. Adjust the vacuum and / or cycle so that you feel comfortable.

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5.3.1. Switching the pump on and off The Carum is switched on by pressing the on / off button once. The display starts with the Welcome page. To switch the Carum off, press the on / off button again.

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CARUM

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CARUM 00:00 Vacuum

Cycles

CARUM 00:00 Vacuum

Cycles

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en 5.3.3. Expression mode – Green background In the expression mode (green background) the Carum switches gently to a higher vacuum and a lower cycle. This automatic change imitates the natural behavior of the baby because it changes its suckling behavior as the breast milk starts to flow. The baby now sucks slower but with a greater suction strength. The vacuum and the cycles can be increased or reduced by pressing the buttons repeatedly or holding them down. The selected settings are shown using bars. Again, you can adjust the vacuum and / or cycle in this mode so that you feel comfortable.

5.3.4. "Sensitive Programme" The "Sensitive Programme" (green background) pumps with a barely detectable vacuum and cycle to enable gentle expressing of milk if you have sore nipples.

CARUM 02:00 Vacuum

Cycles

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CARUM 00:00 Vacuum

Cycles

The vacuum and the cycle can be increased or reduced by pressing the buttons repeatedly or holding them down. The settings are shown using bars. Setting the "Sensitive Programme": 1. Press the on / off button 2. Press the mode button while the Welcome page is being displayed.

CARUM 00:00 Vacuum

5.3.5. Triggering the let-down reflex again In the expression mode (green background), you can switch to the stimulation mode (orange background) at any time by pressing the mode button again. This stimulates the milk flow again.

Cycles

CARUM 00:00 Vacuum

Cycles

The mode button can also be used to change from the two minute stimulation mode to the expression mode ahead of time.

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en 5.3.6. Time measurement / Stopwatch The time measurement starts with switching on the Carum and is displayed in the information ribbon. • The time measurement is stopped by pressing the Time button once. • By pressing the Time button again, the clock is reset to 00:00. • Pressing the Time button again starts the time measurement once more. The time measurement is retained when changing modes but is reset to 00:00 when the Carum is switched off. 5.3.7. Dimmer function The brightness of the display can be reduced by pressing the Dimmer button once; at the same time the light bulb symbol in the information ribbon fades out. By pressing the button again the display returns to its normal brightness.

5.3.8. Carum Battery The Carum Battery with its integrated battery unit is identified on the front panel by "BATTERY".

CARUM 02:00 Vacuum

CARUM 02:00 Vacuum

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Cycles

CARUM BAT TERY 10:00 Vacuum

The battery unit charge status is displayed as a battery symbol in the information ribbon. During recharging, the bars move from left to right until the battery unit is fully recharged.

Cycles

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6. Useful tips 6.1. Expressing must never be painful. • Check that the size of the breast shell fits the size of your nipple (see instructions for use for the pumpset). • Ensure that your nipple is centered in the breast shell. • If your milk is not flowing, a breast massage while expressing may be helpful. • If your nipples are sore or your breasts are painful, preferably use the "Sensitive Programme" without stimulation beforehand. The "Sensitive Programme" starts pumping milk using a very gentle and low vacuum. 6.2. Stimulating the milk let-down reflex Because the let-down reflex when expressing can occur later than with natural breastfeeding, the following tips may be helpful: • Gently massage the breast before expressing milk. • Drink a warm drink. • Think about your baby and relax. • Look at photos of your baby. • Before expressing milk, place a warm "Ardo Temperature Pack" or a warm, damp cloth on the breast. • Warm the breast shell, under running warm water for example, before using it. 6.3. Efficient expressing • By massaging the breast while expressing, you can obtain more milk and improve the milk flow. • Select a vacuum that makes you feel comfortable. 6.4. Increasing the volume of milk • Pump both breasts at the same time (double pumping). • Double pump for the first ten minutes or until milk no longer flows. Then switch to single pumping and pump each breast for five minutes. With the hand that is now free, massage the breast gently before pumping.

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7. Accessories / replacement parts Item

Item number

Euro power cord

63.00.130

UK power cord

63.00.131

US power cord

63.00.132

Mobile stand, optional

63.00.129

Bottle holder

63.00.127

Easy Freeze holder

63.00.128

Various pumpsets and other accessories as well as replacement parts

www.ardomedical.com

8. Error messages / status messages

Error

A fault in the Carum or the Carum Battery is indicated on the display by the adjacent symbol. Please switch the device off and switch it on again. If the fault persists, please have the device inspected by a service point or the manufacturer. A flat battery unit in the Carum Battery is indicated on the screen by the adjacent symbol. When this symbol appears on the display, the Carum Battery switches off automatically after about 5 seconds. Insert the power cord into the device and connect it to the mains power to recharge the battery unit.

8.1. Other possible faults during pumping No vacuum or vacuum is too weak Check that • you are using an original Ardo pumpset. (Always express milk using an Ardo pumpset.) • the second opening on the tube connector is closed. • the tube connector is firmly seated in the connection opening of the pump. • the pumpset is correctly assembled and is not damaged. (See instructions for use for the pumpset) Carum does not function / display remains dark Check that • the power cord and its socket are visually in order and are not faulty. Never use a faulty cord or a cord with faulty plugs! • the power cord is correctly plugged into the Carum and into the power socket. • the Carum works on another power socket. • another device works on the same power socket. If you confirm that the Carum is faulty, please have the device inspected by a service point or the manufacturer.

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9. Cleaning / inspection / maintenance If the cleaning and inspections are not carried out as required, there is a risk of infection or of the device developing a fault. 9.1. Cleaning / disinfection • Always disconnect the Carum from the mains power supply before cleaning! • The Carum is not waterproof which is why it must never be immersed in liquids! Never clean the Carum in a dishwasher, hand basin, or under running water. • You must also ensure that no cleaning liquid enters the connection openings for the pumpset or the electrical connections. Cleaning at home • As required, wipe the outside of the Carum with a damp cloth. You may use a little standard dishwashing detergent if necessary but do not use any abrasive cleaners. • Clean the pumpset in accordance with the directions in the relevant instructions for use. Cleaning in the hospital • Carum: Wipe disinfection of the surfaces with a non-phenolic disinfectant. Do not use abrasive cleaning agents. • Mobile stand for the Carum: Wipe disinfection of the surfaces with a non-phenolic disinfectant. Do not use abrasive cleaning agents. • Clean the pumpset in accordance with the directions in the relevant instructions for use. 9.2. Inspection before switching on • The housing and the display are intact. • The power cord and the power socket are not damaged. • The pumpset is clean, not faulty, and correctly assembled. • The pumpset is correctly connected to the connection opening of the Carum. • Any accessories are clean, not faulty, and correctly assembled. • Mobile stand (optional): Check that the screws are tightened. 9.3. Maintenance The Carum does not in principle need any maintenance. The following inspections are, however, recommended to ensure perfect functioning: 9.3.1. Inspection checklist for hiring Visually inspect the pump for cleanliness

After every hire

Visually inspect the pump for completeness

After every hire

Visually inspect the pump for damage

After every hire

Simple functional check of the pump (if the pump runs, the battery unit is charged)

After every hire

Vacuum check carried out by trained service personnel

At least every 2 years

9.3.2. Inspection checklist for use in hospitals Visually inspect the pump for cleanliness and damage

Before and after each use

Vacuum check carried out by trained service personnel

At least every 2 years

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10. Warranty The warranty period of the Carum breastpump is 3 years from the date of purchase; the dated receipt is considered the certificate of warranty. The warranty period for the reachargeable lithium ion battery unit for the Carum Battery is 1 year from the date of purchase; the dated receipt is considered the certificate of warranty. General warranty conditions Ardo medical AG guarantees that the devices it manufactures are free of material and manufacturing defects. With proper use, material that develops a defect during the warranty period is replaced free of charge. To protect the right to make a warranty claim and to ensure that the device functions without fault, the instructions for use must be followed and only accessories from Ardo medical AG may be used. The warranty benefit is voided if the device has been modified in any way.

11. Technical information 11.1. Technical data Dimensions of the pump L×W×H

320 × 240 × 180 mm

Pump weight

3.0 kg

Pump weight with reachargeable battery unit

3.7 kg

Power cord length

3m

Mains voltage / frequency

100–240 VAC ± 10% / 50/60 Hz

Power consumption

135 VA

Mains fuse input P / N

T 2.5 A / 250 VAC

Connector for car cable

12 V DC

Operating conditions

5–40°C (41–104°F) 10–93% RH, not condensing 700–1060 hPa

Degree of protection (pumpset is an applied part)

BF

Protection class

Class II

Classification as per MDD 93/42/EEC

Class IIa

Dimensions of the mobile stand L×W×H

425 × 425 × 720 mm

Ground clearance

105 mm

Wheel diameter

75 mm

Mobile stand weight

7.0 kg

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en Vacuum (± 5% 1))

Cycle (± 3)

Stimulation mode Start value

60 mbar | 6 kPa | 45 mmHg

90 / min

Setting values

30–150 mbar | 3–15 kPa | 22–113 mmHg

72–120 / min

Start value

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45 / min

Setting values

30–330 mbar | 3–33 kPa | 22–248 mmHg

30–60 / min

Expression mode

"Sensitive Programme" Start value

30 mbar | 3 kPa | 22 mmHg

30 / min

Setting values

30–330 mbar | 3–33 kPa | 22–248 mmHg

30–60 / min

* The expression mode uses the setting value last selected by the user in the stimulation mode and increases the vacuum by 30 mbar / 3 kPa / 22 mmHg 1) The vacuum values are independent of the actual atmospheric pressure.

11.2. Conformity

11.3. EMC test record

As per the Medical Device Directive 93/42 EEC, EN 60601-1, EN 60601-1-2, EN ISO 10079-1, EN 60601-1-6, EN 60601-1-11, 2011/65/EU (RoHS)

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MEDICAL – GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005, C1:09, A2:10), CAN/CSA C22.2 No.60601.1 (2008, R:2011)

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12. Transport and Storage The original packaging must be used to transport and store the Carum and the Carum Battery. We recommend storing the Carum protected against UV light (e.g., sunlight, halogen lamps), heat, and dust. Carum Battery: Please obtain information from the particular airline about transport requirements when flying. Temperature

–20°C to +70°C (–4°F to 158°F)

Relative air humidity

10–93% RH, not condensing

Air pressure

700–1060 hPa

13. Service life and disposal The service life of the device with proper use is 10 years excluding wear parts. This device contains electronic components and a rechargeable lithium ion battery unit. At the end of the service life of the device, the device and its accessories must be disposed of in accordance with the locally applicable regulations. Used reachargeable battery units must not be disposed of in household trash but instead returned to the point of purchase or disposed of in accordance with locally applicable regulations. The device is subject to the requirements of the WEEE Directive.

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EMC Test Report

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Summary of test for Electromagnetic Compatibility The test of electromagnetic compatibility according to IEC / EN 60601-1-2 for this device has shown that in the intended use no endangering of the functional safety or a failure of this device due to electromagnetic influences are to be expected. This device uses HF-energy exclusively for its internal function. Its HF-transmission is therefore very small, and it is therefore unlikely that adjacent electronic equipment will be affected. Since the propagation of electromagnetic variables is affected by absorptions and reflections from structures and / or by objects and people, the following must be observed:

This device should not be operated at a short distance from other devices. Do not place any other devices on the housieng of this device. If it must operate at a short distance from other devices, the device should be observed to verify its intended performance. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device. Mobile radio equipment or mobile phones should not be used at a short distance from this device or its mains power cable. Interference may occur in the vicinity of equipment marked with the symbol adjacent.

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99.03.788 / V01 / 08.2018 Ardo medical AG Gewerbestrasse 19 6314 Unterägeri Switzerland T +41(0)41 754 70 70 F +41(0)41 754 70 71 [email protected] www.ardomedical.com

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