Carum - Breast pump Ardo - Free user manual and instructions

Frequently Asked Questions - Carum Ardo

USER MANUAL Carum Ardo

Black-and-white close-up of a smiling adult gently holding a baby's face (no text or symbols visible)

languages: brauchsanweisung Carum 3-15

ARDO

Your Professional Way to Care

Languages:

Page:

Instructions for use Carum 16–28

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Black-and-white photo of a medical device with a square display and labeled 'm.' (no visible text or symbols on the device itself)

Medical scanner device with digital display and plastic bag, no visible text or symbols

Medical device with digital display and cups, no visible text or symbols

Medical device with digital display and tubing, no visible text or symbols

4.3. Bedienung

MEDICAL - GENERAL MEDICAL EQUIPMENT

AS TO ELECTRICAL SHOOK FIRE AND

Aresomere E.36001-1 (2023, C.T.BF, No 16)

(3)68420

Black cable with a power plug and cord, labeled 'g.' (no other text or symbols)

graph TD
    A["i. Contact"] --> B["h. Contact"]
    B --> C["j. Contact"]
    C --> D["k. Contact"]
    D --> E["l. Contact"]
    E --> F["m. Contact"]
    F --> G["n. Contact"]

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).

TABLE OF CONTENTS

1. IMPORTANT SAFETY DETAILS 18

2. PRODUCT DESCRIPTION 19

2.1. Suckling Curve 19

3. APPLICATION FOR USE 19

3.1. Indications 19

3.2. Contra-indications 19

4. START-UP/OPERATION 20

4.1. Icons 20

4.2. Installation 21

4.2.1. Electrical connection 21

4.2.2. Connecting the PumpSet 21

4.2.3. Installing the bottle holder 21

4.2.4. Installing the EasyFreeze holder 21

4.3. Operation 22

4.3.1. Switch on / switch off 22

4.3.2. Regulation of the vacuum and display 22

4.3.3. Cycle regulation and display 22

4.3.4. Switch stimulation mode / expression mode 23

4.3.5. Using express mode, skipping stimulation mode 23

4.3.6. Timing / Time Button 23

4.3.7. Backlight 23

5. USEFUL TIPS 24

5.1. Adjusting the vacuum (intensity of suction) 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

6. ACCESSORIES 25

7. ERROR ANALYSIS / ERROR DISPLAY /

SERVICE INDICATOR 25

7.1. Further possible errors when using the unit 25

8. MAINTENANCE/CARE/CLEANING 25

8.1. Visual inspection before switch-on 26

8.2. Cleaning/disinfection 26

8.2.1. Checklist: Maintenance inspections for rentals 26

8.2.2. Checklist: Maintenance inspection for hospitals 26

9. GUARANTEE 26

10. TECHNICAL INFORMATION 27

10.1.Version 27

10.2. Technical data 27

10.3. Compliance 27

10.4. EMV Test records 27

11. TRANSPORT/STORAGE/DISPOSAL 28

11.1. Transport and storage conditions 28

11.2. Disposal 28

12. APPENDIX 185

12.1. EMV Test records 185

1. IMPORTANT SAFETY DETAILS

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 damage to the unit and to avoid risk of electric shock, injury or fire, please observe the following safety regulations.

Safety Regulations

• After use, disconnect Carum from the mains.
- In the event of an accidental splash, or the unit falling into water - IMMEDIATELY disconnect it from the mains. Do not touch the unit until it has been disconnected.
- Disconnection from the mains is only guaranteed if the mains plug is pulled out of the socket.
- The unit is designed for indoor use only. Do not use outdoors.
- Use only the original power cord or car battery cable from ARDO.
- Do not open the unit (results in voiding of the warranty).
- Carum is not water-proof. Therefore the unit must never be immersed in water or other fluids, nor used or stored in places where it might fall into the water. Do not use while in the bath or while taking a shower.
- Keep the mains cable and all accessories away from sources of heat.
- Do not use Carum in an area where oxygen gas is in use or sprays are being applied.
- Only use a genuine ARDO PumpSet and genuine ARDO parts. See Section 4. (Start-up / Operation) and Section 8 (Maintenance/Care/Cleaning).
- Carum should only be used for the purposes detailed in Section. 2 (Application).

Battery option and car battery adapter

• The unit is designed for indoor use only. Do not use outdoors.
• If the operating time of the battery declines from fully charged to less than one hour (of charge), the battery should be changed as soon as possible, to ensure safe operation of the Carum when on battery power. See Section 8: Maintenance/Care/Cleaning.
• Do not use the Carum out in the open when operating on the car cigarette-cable.
• Caution: Ensure that the car battery delivers 12 volts.
• The unit must not be altered or changed without the express permission of the manufacturer.
• Any alteration or change to the Carum is not permitted.
• If the Carum must be altered or changed to ensure safe continued use, the appropriate studies and testing must be carried out.
• Please keep this User Manual handy for reference at all times.

2. PRODUCT DESCRIPTION

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.

The sophisticated controls allow each mother to enjoy a comfortable and efficient pumping experience (plus a tested suckling curve) thanks to the flexible system for adjusting vacuum and cycles.

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

• To increase and maintain the ability to breastfeed.
- Ensure the supply of breast milk should mother and baby be separated.
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.

4. START-UP / OPERATION

4.1. Icons

IP21

Li-Ion

Read the manual

Important information

"ON/OFF" switch

Suckle strength / Adjust the vacuum (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

Assembling

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

IP 21 drip proof

Contains a lithium ion battery

Express mode

Stimulation mode

Device is recyclable

4.2. Installation

4.2.1. Electrical connection

• Mains operation: Insert mains cable (A) into the Carum mains (B) input socket (Fig.1) and connect the local power plug to the mains power supply.
• Battery operation: Before using the battery for the first time, 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.

- To use the single PumpSet: Attach the tube connector (C) to the unit (D). (Fig. 2).

- To use the double PumpSet: Attach the tube connector to the unit (Fig 3).

- The second opening of the tube connector (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.

B A

C D E

Close-up of a medical or laboratory device with liquid and cups, no visible text or symbols

Medical device with digital display and plastic cup, no visible text or symbols

4.3. Operation

Vacuum and cycles can be adjusted independently of each other. Select the adjustment which is the most comfortable for you.

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

The vacuum (suction strength) can be adjusted, 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

The cycles (frequency) can be adjusted, 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.

Curum Welcome ARDO ARDO

Carum ARDO

Carum 30-40A Calcium Cycles 200 ARDO

4.3.4. Switch stimulation mode / expression mode

To change the stimulation mode display screen (orange display) to the express mode display screen (green display), press the 'Mode' button just 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 be individually adjusted.

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.

Corum RR-42 Status Cycles ARDO

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.

Carumi Welcome ARDO ARDO

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.

Corum ARDO

4.3.7. Backlight

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.

Corlum Control Control ARDO

5. USEFUL TIPS

5.1. Adjusting the vacuum (intensity of suction)

Expressing milk should never be painful.

• Set the vacuum intensity at the highest level which is comfortable for you.
  • Take care that the nipple is centred in the breast-shell.
• Check whether the size of the breast-shell fits your nipple. (See the User Manual: "ARDO PumpSet").
• In the event that the milk is not released, try massaging the breast – this can be really effective.

Regulate the vacuum by touching the arrow keys.

• Intensify the vacuum, until you feel a very slight discomfort, and then reduce the intensity of the vacuum until pumping is comfortable.
• In the event of sore nipples or painful breasts, skip the stimulation mode. The Carum will then start in express mode with an especially mild, gentle and low level vacuum.
• It is recommended that, in pump- or stimulation mode, you adjust the suction strength each time to suit your personal comfort level. This is because the vacuum level generated is sensitive to prevailing atmospheric pressure.

5.2. Regulate the cycle

- When babies start to breast feed, they suckle with rapid sucking motions and low suction – this causes the milk to release by stimulating the milk ejection reflex.

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.

• Select stimulation mode, choose the level of vacuum which feels most comfortable.
• When the milk begins to flow, the baby's sucking pattern changes. The baby sucks more slowly, but more 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.
• If the milk flow falters, return to stimulation mode to prompt renewed milk flow.

5.3. Encouraging the Let down reflex

The milk ejection reflex may occur later when pumping than when breast feeding. The following measures may be helpful.

• Have a warm drink.
• Relax and think about your baby.
• Look at a picture of your baby.
• Apply a warmed compress to the breast before expressing (e.g. ARDO Temperature Pack).
• Warm the cone or funnel of the breast shell before applying.

5.4. Pump efficiently

- Massaging the breast while using the breastpump can boost milk production, and promote better milk flow.

5.5. Increase the quantity of milk

• Use a double pump-set.
• For the first 10 minutes, or until no more milk is flowing, use a double pump i.e. express from both breasts at once. Afterwards, switch to a single pump. Express from each breast for five minutes while massaging gently.

6. ACCESSORIES

Mains cable Euro Art. No. 63.00.130
Mains cable UK Art. No. 63.00.131
Mains cable UL Art. No. 63.00.132
Trolley - optional Art. No. 63.00.129
Car battery adapter 12VDC - optional Art. No. 63.00.133
Bottle holder Art. No. 63.00.127
EasyFreeze holder Art. No. 63.00.128
Various pumpsets www.ardomedical.com

7. ERROR ANALYSIS / ERROR DISPLAY / SERVICE INDICATOR

Identifiable errors or service / maintenance schedules are represented on the LCD by a warning triangle.

7.1. Further possible errors when using the unit

- Weak or absent vacuum

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

- The pump is not working / no data on the LCD display

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.

8.1. Visual inspection before switch-on

• Is the pump housing intact?
• Is the mains power unit undamaged?
• Is the accessory clean, complete and intact?
• Is the accessory correctly attached?

Ignoring these checks, or the cleaning instructions, may lead to risk of infection, electric-shock or damage to the unit.

8.2. Cleaning / disinfection

• Carum breast milk pump:
• The Carum is not waterproof. It conforms to enclosure IP (Ingress Protection) rating IP20.
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).
- Accessory PumpSet: Please read the separate User Manual, Section: Cleaning.

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

8.2.1. Checklist: Maintenance inspections for rentals

• Visual inspection of the pump for cleanliness After every renting
• Visual inspection of the pump for completeness After every renting
• Visual inspection of the pump for damage After every renting
• Simple operational checks of the pump (Pump runs properly, battery charged	After every renting
• Check of the vacuum strength – to be carried out by trained service personnel	Minimum every 2 years

8.2.2. Checklist: Maintenance inspection for hospitals

• Visual inspection of the pump for cleanliness Before every use
• Visual inspection of the pump for damage After every use
• Check of the vacuum strength – to be carried out by trained service personnel	Minimum every 2 years

9. GUARANTEE

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.

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	LxBxH = 302x240x180 mm
Pump weight 3 kg Weight with battery 3.7 kg
Input voltage	100 – 230 VAC +/-10%
DC Input	12 VDC
Operating temperatures	+5 – +40 °C
Protection level	BF
Protection Category Double Insulated	Category II

Power cable length Length	3 m
Frequency	50–60Hz
Lifetime (excluding parts subject to wear and tear)	10 years
Relative humidity	10–93%
Air pressure	700–1060 hPa
Classification in accordance with MDD93/42	Category 2a

Cycle and vacuum levels

Vacuum range in stimulation mode	30-150 mbar22-98 mmHg3-13 kPa
Vacuum range in expression mode	30-330 mbar22-250 mmHg3-33 kPa
Permitted tolerance of the vacuum strength	+/- 5%

Cycle range in stimulation mode	72–120/min.
Cycle range in expression mode	30–60/min.
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

CE0123

MEDICAL -GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSUAIR ES6001-1 (2005, C119, A2 10). CAMOSA-C22.2 No 6001.1 (2008, R 2011)

10.4. EMV Test records

See annex 12.1.

11. TRANSPORT / STORAGE / DISPOSAL

For the transport and storage of your Carum, we recommend using the original packaging. We further recommend separate storage for the unit is protected from UV (e.g. sunlight / halogen lamps), heat and dust.

11.1. Transport and storage conditions

Carum und Carum with optional battery

Temperature -20 – +70°C
Relative humidity 10 – 80%
Air pressure 700 – 1060 hPa

11.2. Disposal

The unit may be returned to the manufacturer, or be dismantled and recycled (as metal or plastic) in an environmentally-friendly manner, through a recycling firm specialising in electrical goods. There are no special or increased risk factors.

Manufacturer:

medical AG

Gewerbestrasse 19

6314 Unterägeri

Switzerland

Homepage: www.ardomedical.com

Email: [e-mail]

EXPLICATIONS

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Medical device with digital display and plastic bag, no visible text or symbols

3. APPLICATIONS/INDICATIONS 32

3.1. Indications 32
3.2. Contre-indications 32

4. MISE EN SERVICE / UTILISATIONN 33

4.1. Légendes 33
4.2. Installation 34

12.1. Homologations CEM 185

1. REMARQUES IMPORTANTES CONCERNANT LA SECURITE

3. APPLICATIONS / INDICATIONS

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4.3. utilisation

10.4. Homologation CEM

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i. h.

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C.

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b.

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Medical device with digital display and plastic bag, no visible text or symbols

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Medical device with digital display and medical tubing (no visible text or symbols)

4.3. uso

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Medical device with digital display and plastic bag, no visible text or symbols

2. PRODUCTBESCHRIJVING 58

2.1. Zuigcurve 58

3. TOEPASSINGEN/INDICATIES 58

3.1. Indicaties 58

3.2. Contra-indications 58

4. INGEBRUIKNEMING/BEDIENING 59

4.1. Legende 59

4.2. Installatie 60

2. PRODUCTBESCHRIJVING

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Medical device with digital display and cups, no visible text or symbols

Medical device with digital display and plastic cup, no visible text or symbols

4.3. Bediening

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Cross-sectional view of a mechanical or electronic component with internal channels and labeled part 'k.' (no readable text or symbols beyond the label)

Interior view of a rectangular device with a central display and labeled component 'I.' (no text or symbols on the device itself)

Black-and-white photo of a medical device with a square display and a label 'm.' (no visible text or symbols on the device itself)

Medical device with digital display and plastic bag, no visible text or symbols

Medical device with digital display and cups on a surface (no visible text or symbols)

Medical device with digital display and tubing, no visible text or symbols

4.3. Manejo

Carum ARCO

Corum 300-45 Cycles 1000mm 2000mm ARDO

Corum Minimum Cycles ARDO

Carumi Welcome ARDO ARDO

Carum ARDO

Carium Status Carium ARDO

5. CONSEJOS ÚTILES

3. APLICAÇÕES/INDICAÇÕES 84

3.1. Indicações 84

3. APLICAÇÕES / INDICAÇÕES

Medical device with digital display and cups on a surface (no visible text or symbols)

Medical device with a digital display and tubing, no visible text or symbols

4.3. Operação

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graph TD
    A["i. Contact"] --> B["h. Contact"]
    B --> C["j. Contact"]
    C --> D["k. Contact"]
    D --> E["l. Contact"]
    E --> F["m. Contact"]
    F --> G["n. Contact"]

Close-up of a white electronic device with digital display and cups, no visible text or symbols

Medical device with digital display and medical tubing (no visible text or symbols)

4.3. kullanım

Corum 40.14 Tension Control AR00

4.3.7. Fon aydınlatması

MEDICAL - GENERAL MEDICAL EQUIPMENT

AS TO ELECTRICAL SHOOK FIRE AND

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graph TD
    A["i. Contact"] --> B["h. Contact"]
    B --> C["j. Contact"]
    C --> D["k. Contact"]
    D --> E["l. Contact"]
    E --> F["m. Contact"]
    F --> G["n. Contact"]

3. ANVENDELSE / INDKATIONER

Medical procedure images showing step-by-step instructions for a device with labeled parts A, B, C, and D, plus a close-up of component E.

Close-up of a kitchen appliance with liquid being poured into cups (no visible text or symbols)

4.2.4. Montering af EasyFreeze holderen

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4.3. Betjening

Coiled black cable with a terminal plug, labeled 'g.' (no other text or symbols)

graph TD
    A["i. Contact"] --> B["h. Contact"]
    B --> C["j. Contact"]
    C --> D["k. Contact"]
    D --> E["l. Contact"]
    E --> F["m. Contact"]
    F --> G["n. Contact"]

INNEHÅLLSFÖRTECKNING

1. VIKTIG SÄKERHETSINFORMATION 122

2. PRODUKTBESKRIVNING 123

2.1. Sugkurva 123

3. ANVÄNDNINGSOMRÅDEN/INDIKATIONER 123

3.1. Indikationer 123

3.2. Kontraindikationer 123

4. IDRIFTTAGNING / ANVÄNDNING 124

Medical device with digital display and cups, no visible text or symbols

Medical device with digital display and tubing, no visible text or symbols

4.3. Användning

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graph TD
    A["i. Contact"] --> B["h. Contact"]
    B --> C["j. Contact"]
    C --> D["k. Contact"]
    D --> E["l. Contact"]
    E --> F["m. Contact"]
    F --> G["n. Contact"]

3. BRUK / INDIKASJONER

Medical device with digital display and cups, no visible text or symbols

Medical device with digital display and glass container (no visible text or symbols)

4.3. Betjening

Corum AR00

Comms Control Action System ARDO

5. NYTTIGE TIPS

Black cable with a power plug and tied cord, labeled 'g.' (no other text or symbols)

graph TD
    A["i. Contact"] --> B["j. Contact"]
    B --> C["k. Contact"]
    C --> D["l. Contact"]
    D --> E["m. Contact"]
    E --> F["n. Contact"]

3. KÄYTTÖ / KÄYTTÖAIHEET

Medical device with digital display and cups, no visible text or symbols

4.2.4. EasyFreeze -telineen asennus

Medical device with digital display and tubing, no visible text or symbols

4.3. käyttö

MEDICAL - GENERAL MEDICAL EQUIPMENT

AS TO ELECTRICAL SHOOK FIRE AND

MECHANICAL HAZARDS CHE

IN ACCORDANCE WITH

ANSUAMB ES60521-1 G005 C1-99, A2-103

CAN/CSA C22 2 No 60601 1 (2008, R:2011)

Interior view of a mechanical housing with internal components and mounting holes (no text or symbols visible)

Cross-sectional view of a mechanical or electronic component with internal channels and labeled part 'k.' (no readable text or symbols beyond the label)

Interior view of a rectangular device with a central display and labeled component 'I.' (no text or symbols on the device itself)

Black-and-white photo of a medical device with a square display and a labeled tag 'm.' (no visible text or symbols on the device itself)

Medical device with digital display and plastic bag, no visible text or symbols

| x | y | | ---- | ----- | | 0 | -1.0 | | 1 | 0.0 | | 2 | 1.0 | | 3 | -1.0 | | 4 | 0.0 | | 5 | 1.0 | | 6 | -1.0 | | 7 | 0.0 | | 8 | 1.0 | | 9 | -1.0 | | 10 | 0.0 | | 11 | 1.0 | | 12 | -1.0 | | 13 | 0.0 | | 14 | 1.0 | | 15 | -1.0 | | 16 | 0.0 | | 17 | 1.0 | | 18 | -1.0 | | 19 | 0.0 | | 20 | 1.0 | | 21 | -1.0 | | 22 | 0.0 | | 23 | 1.0 | | 24 | -1.0 | | 25 | 0.0 | | 26 | 1.0 | | 27 | -1.0 | | 28 | 0.0 | | 29 | 1.0 | | 30 | -1.0 | | 31 | 0.0 | | 32 | 1.0 | | 33 | -1.0 | | 34 | 0.0 | | 35 | 1.0 | | 36 | -1.0 | | 37 | 0.0 | | 38 | 1.0 | | 39 | -1.0 | | 40 | 0.0 | | 41 | 1.0 | | 42 | -1.0 | | 43 | 0.0 | | 44 | 1.0 | | 45 | -1.0 | | 46 | 0.0 | | 47 | 1.0 | | 48 | -1.0 | | 49 | 0.0 | | 50 | 1.0 | | 51 | -1.0 | | 52 | 0.0 | | 53 | 1.0 | | 54 | -1.0 | | 55 | 0.0 | | 56 | 1.0 | | 57 | -1.0 | | 58 | 0.0 | | 59 | 1.0 | | 60 | -1.0 | | 61 | 0.0 | | 62 | 1.0 | | 63 | -1.0 | | 64 | 0.0 | | 65 | 1.0 | | 66 | -1.0 | | 67 | 0.0 | | 68 | 1.0 | | 69 | -1.0 | | 70 | 0.0 | | 71 | 1.0 | | 72 | -1.0 | | 73 | 0.0 | | 74 | 1.0 | | 75 | -1.0 | | 76 | 0.0 | | 77 | 1.0 | | 78 | -1.0 | | 79 | 0.0 | | 80 | 1.0 | | 81 | -1.0 | | 82 | 0.0 | | 83 | 1.0 | | 84 | -1.0 | | 85 | 0.0 | | 86 | 1.0 | | 87 | -1.0 | | 88 | 0.0 | | 89 | 1.0 | | 90 | -1.0 | | 91 | 0.0 | | 92 | 1.0 | | 93 | -1.0 | | 94 | 0.0 | | 95 | 1.0 | | 96 | -1.0 | | 97 | 0.0 | | 98 | 1.0 | | 99 | -1.0 | | = >2, = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =

-1

-2

3. ZAKRES STOSOWANIA / WSKAZANIA

Medical device with digital display and cups, no visible text or symbols

Medical device with digital display and tubing, no visible text or symbols

4.3. Obsługa

Corum 30-45 Vacuum Cycles 100% 0.0 ARDO

Producent: medical AG

Gewerbestrasse 19

6314 Unterägeri

Switzerland

Coiled black cable with a terminal power plug, labeled 'g.' (no other text or symbols)

graph TD
    A["i. Contact"] --> B["j. Contact"]
    B --> C["k. Contact"]
    C --> D["l. Contact"]
    D --> E["m. Contact"]
    E --> F["n. Contact"]

Black-and-white photo of a kitchen appliance with digital display and cups (no visible text or symbols)

Medical device with digital display and medical tubing (no visible text or symbols)

4.3. Χρήση

TEST REPORTIEC / EN 60601-1-2Part 1-2: Electromagnetic Compatibility Requirements and Tests
Report reference No:	E1541-05-1*
Tested by:	B. Belegu
Approved by management:	Dr. F. Stuck
Date of issue:	26 April 2011
Number of pages:	1 page
Testing laboratory:	QUINEL AG	SSTS Schweizerischer Prüfstellendenst Service Susse d'essai Servizio di prova in Svizzera Swiss testing service
Address:	Grundstr. 2 CH-6343 Rotkreuz
Testing location:	Rotkreuz Tel. [phone]
Applicant's Name:	Ardo Medical AG, Mr. Christian Waser
Address:	Gewerbestrasse 19, CH-6314 Unterägeri
Manufacturer:	Ardo Medical AG
Address:	Gewerbestrasse 19, CH-6314 Unterägeri
Test specification:
Standards:	IEC 60601-1-2:2007, EN 60601-1-2:2007
Test procedure:	Type testing for Swiss and EU legal requirements
Procedure deviation:	None
Non-standard test method:	None
Test-specification:	The used test setup fulfils the specification described in the relevant standards
Test item description:	Breast Pump
Trademark:	Ardo
Model and/or type reference:	Carum
Ratings:	100V-240V AC, 50Hz-60Hz
Date of receipt of the test item(s):	06 April 2011
Summary of testing:	Passed

Applied standards:

Title	Standard (up dated)
RF disturbances	CISPR 22:2008, EN 55022:2010
RF conducted disturbances	IEC 61000-4-6:2008, EN 61000-4-6:2009
Radiated electromagnetic field	IEC61000-4-3:2006+A1:2007+A2:2010, EN 61000-4-3:2006+A1:2008+A2:2010
Power frequency magnetic field	IEC 61000-4-8:2009, EN 61000-4-8:2010
Electrical fast transient burst	IEC 61000-4-4:2004+A1:2010, EN 61000-4-4:2004+A1:2010
Electrostatic discharge	IEC 61000-4-2:2008, EN 61000-4-2:2009
Surge	IEC 61000-4-5:2005, EN 61000-4-5:2006
Voltage dips - interruptions	IEC 61000-4-11:2004, EN 61000-4-11:2004
Harmonic current emissions	IEC 61000-3-2:2005+A1:2008+A2:2009, EN 61000-3-2:2006+A1:2009+A2:2009
Voltage fluctuations and flicker	IEC 61000-3-3:2008, EN 61000-3-3:2008

Acceptance criteria/operating conditions:

During and after the test the apparatus should show no damage or loss of information and should function according to specifications.

This Test Report is, together with the Test Report E1541-05a-11 and E1541-05b-11, valid for the following types: Carum 1, Carum 2

TEST REPORTIEC / EN 60601-1-2Part 1-2: Electromagnetic Compatibility Requirements and Tests
Report reference No:	E1541-05-1*
Tested by:	B. Belegu
Approved by management:	Dr. F. Stuck
Date of issue:	26 April 2011
Number of pages:	1 page
Testing laboratory:	QUINEL AG	SSTS Schweizerischer PrüftstellendienstService Suisse d'essaiServizio di prova in SvizzeraSwiss testing service
Address:	Grundstr. 2 CH-6343 Rotkreuz
Testing location:	Rotkreuz Tel. [phone]
Applicant's Name:	Ardo Medical AG, Mr. Christian Waser
Address:	Gewerbestrasse 19, CH-6314 Unterägeri
Manufacturer:	Ardo Medical AG
Address:	Gewerbestrasse 19, CH-6314 Unterägeri
Test specification:
Standards:	IEC 60601-1-2:2007, EN 60601-1-2:2007
Test procedure:	Type testing for Swiss and EU legal requirements
Procedure deviation:	None
Non-standard test method:	None
Test-specification:	The used test setup fulfils the specification described in the relevant standards
Test item description:	Breast Pump
Trademark:	Ardo
Model and/or type reference:	Carum
Ratings:	100V-240V AC, 50Hz-60Hz
Date of receipt of the test item(s):	06 April 2011
Summary of testing:	Passed

Applied standards:

Title	Standard (up dated)
RF disturbances	CISPR 22:2008, EN 55022:2010
RF conducted disturbances	IEC 61000-4-6:2008, EN 61000-4-6:2009
Radiated electromagnetic field	IEC61000-4-3:2006+A1:2007+A2:2010, EN 61000-4-3:2006+A1:2008+A2:2010
Power frequency magnetic field	IEC 61000-4-8:2009, EN 61000-4-8:2010
Electrical fast transient burst	IEC 61000-4-4:2004+A1:2010, EN 61000-4-4:2004+A1:2010
Electrostatic discharge	IEC 61000-4-2:2008, EN 61000-4-2:2009
Surge	IEC 61000-4-5:2005, EN 61000-4-5:2006
Voltage dips - interruptions	IEC 61000-4-11:2004, EN 61000-4-11:2004
Harmonic current emissions	IEC 61000-3-2:2005+A1:2008+A2:2009, EN 61000-3-2:2006+A1:2009+A2:2009
Voltage fluctuations and flicker	IEC 61000-3-3:2008, EN 61000-3-3:2008

Acceptance criteria/operating conditions:

During and after the test the apparatus should show no damage or loss of information and should function according to specifications.

This Test Report is, together with the Test Report E1541-05a-11 and E1541-05b-11, valid for the following types: Carum 1, Carum 2

Medical device labeled 'Carum' with AROO branding, shown in grayscale (no readable text beyond branding)

ARDO

Ardo medical AG

Gewerbestrasse 19

6314 Unterägeri

Switzerland

T [phone]

F [phone]

[e-mail]

www.ardomedical.com