ardo AR63.00.6 Calypso Electric Breast Pump Instruction Manual

ardo AR63.00.6 Calypso Electric Breast Pump [

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Thank you for choosing the gentle Calypso breast pump from Ardo.
In these instructions, you will find important and useful details which will make your Calypso experience even more rewarding.

Product description[

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a. Calypso breast pump
b. Pumpset (applied part, see separate instructions for use, enclosed)
c. Tube connector
d. Control panel
e. LCD display
f. Connection opening for tube connector
g. Power adapter
h. Unit plug
i. Electrical connection socket

Calypso is a vacuum pump with a one piston system. The controls allow each mother to customize the settings through a flexible system for adjusting vacuum and cycles. The vacuum level remains stable when the user changes the cycle settings. Likewise, the cycle remains stable when the user changes the vacuum settings. The minimum requirement to the patient / operator: she has to be able to read and understand these instructions for use.

Important safety details

Calypso is an electrically-operated, safe and reliable breastpump for personal use. Calypso is constructed and assembled in accordance with CE guidelines, and in compliance with safety standards (see section 9.2 Compliance). 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. The patient is also the intended operator.
The maximum temperature of the enclosure will be 50 °C. Under all conditions the contact of the patient with the pump unit must not be longer than 1 minute. During this time no clinical effects will occur. Skin irritation can appear when contacting the pump unit too long.

Key to symbols

Safety Regulations

• After use, disconnect the Calypso from the mains power source by pulling the power adapter out of the socket.

• Disconnection from the outlet is only guaranteed if the power adapter is pulled out of the socket.

• Do not leave old batteries in the unit – danger of leakage.

• When using the unit connected to the mains, remove the batteries (danger of leakage).

• 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.

• The Calypso with the power adapter is designed for indoor use only. Do not use outdoors.

• Use the unit with the Ardo power adapter only.

• Do not open the unit (no user-serviceable parts).

• Calypso 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 power adapter and all accessories away from sources of heat.

• Do not use Calypso 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 7 (Maintenance / Care / Cleaning).

• Calypso should only be used for the purposes detailed in section 3 (Intended use).

• Please keep these instructions for use handy for reference at all times.

• Do not change the batteries during operation.

Intended use

The Calypso breastpump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only.

Start-up / Operation

For assistance in setting up, using or maintaining the breastpump please contact the point of sale or authorized
service personnel.

Controls

Stand-by switch
Adjust the suction strength/vacuum (V)
Change the suction frequency/cycles (C)

Preparing the pump for use

Mains operation:

• Insert the unit plug (h) of the power adapter (g) into the electrical connection socket (i) of the unit (Fig. 1). The power adapter must correspond to the local mains electricity supply.
  Important: remove the batteries before plugging the unit into the mains. Battery operation:

• Release the latch (Fig. 2) and slide open the battery cover.

• Six LR 06 / AA batteries are required for use. Check the
  + / – mark orientation of the batteries (Fig. 3).

• Close the battery compartment cover and secure by re-engaging the latch (Fig. 4). The average working life with a medium vacuum and cycle setting is approximately 5 hours (Duracell batteries). We recommend that you use Duracell batteries.

Connecting the pumpset

The pumpset is an applied part of Calypso. Use of the pumpset (b) is detailed in the separate “Ardo Pumpset” instructions for use.

• To use the single pumpset: attach the tube connector (c) to the pump (f) (Fig. 5). The second opening of the tube connector remains closed.
• To use the double pumpset: Open the second opening of the tube connector and attach the second pumpset (Fig. 6).
• Attach the tube connector (c) to the pump (f) (Fig. 7).

Operation

The vacuum (suction strength) and cycle (suction frequency) can be adjusted independently of each other. Touching the switches changes the intensity of the vacuum or the cycle by one level.

• Turn on the pump by touching the stand-by switch (Fig. 8). The green LED display will light up. Choose the settings which you find most comfortable.
• Touch the up-arrow to increase the intensity of the vacuum (suction strength). Touch the down-arrow to reduce the vacuum (Fig. 9).
• Touch the up-arrow to step-up the cycle (suction frequency). Touch the down-arrow to reduce the cycle (Fig. 10).

Pumping

Pumping milk should never be painful.

Starting pump

• Wash your hands thoroughly.
• Attach the pumpset to the Calypso.
• Sit down comfortably and relax.
• Centre the nipple so that, when pumping, it moves freely in the funnel of the breast shell / breast shell insert.
• Fill breast shell with the breast to create an air seal.
• Switch on the pump.

Adjusting the vacuum (suction strength)

• Regulate the vacuum by pressing 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.

Adjusting the cycle (suction frequency)

• Regulate the cycle by pressing the arrow keys.
• Set the cycle at the highest level which is comfortable for you.

Encouraging the milk ejection reflex

• When babies start to breastfeed, they suckle with rapid sucking motions and low suction strength – this causes the milk to release by stimulating the milk ejection reflex. This effect can be replicated by starting with a higher cycle level (e.g. 8 bars) and selecting a weaker vacuum.
• When the milk begins to release, reduce the cycles by pressing the down arrow and strengthen the vacuum by pressing the up-arrow until you find the most comfortable level for you.

The milk ejection reflex may occur later when pumping than when breastfeeding. The following measures may be helpful:

• Massage the breast before expressing.
• Relax and think about your baby.
• Gaze at a picture of your baby.
• Apply a warmed compress to the breast before expressing.
• Warm the cone or funnel of the breast shell before applying.

Pumping efficiently

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

Increasing the quantity of milk

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

Troubleshooting

In the event of an error, the LED display flashes green and orange alternately.

General error
Switch off the unit and re-start. If the error message appears again, the unit is defective and cannot be repaired.

Further possible errors when using the unit

• Weak or absent vacuum:
  Disconnect the pumpset from the unit. Partly close the connector opening (f) with a finger to test the suction. However, be careful not to completely cover the opening. If suction is detectable, then the pump is working. Test the pumpset in accordance with the separate instructions for use (only use the original Ardo pumpset).

• The pump is not working / no data on the display:
  Check the electrical supply; if the unit still does not work it is defective.

• In the event that one of these errors occurs, and is confirmed, the unit must be brought or sent back to the point of sale. The unit must be checked out by trained service personnel, or by the manufacturer of the pump unit.

Maintenance / Care / Cleaning

The membrane pot integrated into the pumpset (“Vacuum Seal” technology) ensures that no breast milk or air can get into the tube or Calypso unit. The closed system is so secure that it constitutes a barrier against cross contamination (infection).
The unit is maintenance-free; care of the unit and its accessories is limited to inspection and cleaning. There are no
user-serviceable parts in the Calypso breastpump. With the exception of the power adapter (g), there are no spare parts.

Visual inspection by the user before switch-on

• Is the power adapter (g) 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.

Cleaning / disinfection

• Calypso breastpump:
  Important: Unplug the unit from the power adapter before cleaning.
  Cleaning at home: As needed, wipe with a damp cloth, commercial detergent may be used. 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).
  Calypso is not waterproof. It complies with Standard IP21.

• Accessory pumpset: Please read the separate instructions for use, section: Cleaning.

Warranty

The warranty time-limit for the Calypso, in personal use, is 400 hours (as long as the green LED display lights up). However, there is at the least the stipulated minimum legal warranty period from the date of purchase. The warranty is limited to the original purchaser.

General terms and conditions
Ardo medical AG guarantees its products in respect of materials and manufacturing defects. The warranty period starts from the date of purchase. Defective materials will be replaced free-of-charge, during the life of the warranty, provided that the warranty has not been voided by unauthorised use or access to the unit. To ensure warranty cover, and the flawless functioning of the unit, the instructions for use must be followed, and only Ardo accessories used. The warranty is void if the unit has been opened or tampered with.

NB
After 400 hours, the green LED display changes to orange. This means that the additional warranty has expired. The Calypso can however still be used without any reduction in performance.

Technical information

9.1 Technical data

Pump dimensions| 190 x 130 x 76 mm| Power adapter input voltage| 100 – 240 Volt AC
Power adapter dimensions| 75 x 46 x 31 mm| Frequency| 50 Hz / 60 Hz
Pump weight| 0.545 kg| Internally powered medical equipment| 9 Vdc, 1.4 A
Power adapter weight| 0.150 kg| Power adapter MLF-C06 0901400 output| 9 Vdc, 1.4 A
Classification in accordance with MDD93/42| Class IIa| Power adapter UE15WCP1 0901400 output| 9 Vdc, 1.4 A
Double insulated protection class| Class II| Vacuum range| 50 – 330 mbar, 5 – 33 kPa
Protection level| BF| Permitted tolerance of the vacuum strength| ± 5 %
Life time

(excluding normal wear and tear)

| 800 hours| Operating temperature Relative humidity

Air pressure

| +5 – 40 °C

10 – 93 %

700 – 1060 hPa

Compliance

In accordance with Medical Devices Directive MDD 93/42 EEC, EN 60601-1, EN60601-1-2, EN ISO 10079-1, EN 60601-1-6, EN60601-1-11, 2011/65/EU (RoHS)

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

Transport / Storage / Disposal

For the transport and storage of your Calypso unit, we recommend using the original packaging. We further recommend separate storage protected from UV (e.g. sunlight/halogen lamps), heat and dust (Avoid storing or using the unit on a heater. Do not store or use the unit in a dusty environment. Failure to observe these instructions can lead to the malfunction of the unit).

Transport and storage conditions

Temperature| +5° C (41 °F) to +40 °C (104 °F)
Relative humidity| 30 – 75 %
Air pressure| 700 – 1060 hPa

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 specializing in electrical goods. There are no special or increased risk factors.
Disposal of waste products need to be in accordance with local regulations.

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

References

• Ardo products for breastfeeding, pregnancy and childbirth

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