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Electric Breast Pump User Manual

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Electric Breast Pump User Manual

 

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User manual

 

CALYPSO
ELECTRIC BREASTPUMP
Instructions for use | Instrucciones de uso

Questions: visit www.ardo-usa.com or call us at 844-411-ARDO (2736)
Congratulations on your purchase and thank you for
choosing the gentle Calypso breastpump from Ardo.
Table of contents
1.
Important safety information
2.
Intended use
3.
Product description
4.
Start-up / Operation
5.
Useful tips
6.
Troubleshooting
7.
Maintenance / Care / Cleaning
8.
Warranty
9.
Technical Information
10. Transport / Storage / Disposal
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1. Important safety information
READ ALL INSTRUCTIONS BEFORE USING THIS PRODUCT.
When using electrical products, especially when children are present, basic safety precautions should always be followed.
DANGER: To reduce the risk of electrocutions:
Always unplug electrical product immediately after use.
Do not use while bathing, showering or swimming.
Do not place or store product where it can fall or be pulled into a tub or sink.
Do not place or drop into water or other liquid.
Do not reach for a product if it has fallen into water. Immediately unplug from electrical outlet.
WARNING: To avoid damage, electric shock, injury or fire:
Never leave product unattended when plugged into electrical outlet.
Close supervision is necessary when this product is used near children or persons with disabilities.
Use product only for intended use as described in this manual.
Only use attachments recommended by the manufacturer.
Never operate this product if it has a damaged cord or plug, if it is not working properly, if it has been dropped or
damaged, or dropped into water.
Keep cord and all attachments away from heated surfaces.
Never use while sleeping or when drowsy.
Do not use outdoors, or operate where aerosol (spray) products are being used where oxygen is being administered.
Batteries should be removed from the product when using the AC.
Use the unit with the Ardo power adapter only.
Do not leave old batteries in the unit – danger of leakage.
This product is intended for use by a single user only and should not be shared between users.
Do not shorten the tubing.
Never use while pregnant, as pumping can induce labor.
Clean and sanitize all parts that come in contact with your breast and breast milk prior to first use.
Do not use solvents or abrasives.
If pumping is uncomfortable or causing pain, turn the unit off, break the seal between the breast and breastshell with
your finger and remove the breastshell from your breast.
SAFE THESE INSTRUCTIONS
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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Questions: visit www.ardo-usa.com or call us at 844-411-ARDO (2736)
3. Product description
a
Calypso breastpump
b
Pumpset (may vary with different models)
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
2. Intended use
The Calypso breast pump 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 and is intended for single users.

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Questions: visit www.ardo-usa.com or call us at 844-411-ARDO (2736)
4. Start-up / Operation
4.1 Controls
4.2 Preparing the pump for use
Outlet 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 electricity supply.
Important: remove the batteries before plugging the unit into
the outlet.
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-engag
-
ing 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.
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2
3
4
Stand-by switch
Adjust the vacuum (V)
Adjust the cycle (C)
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 connec-
tor 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).
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6
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4.3 Operation
The vacuum (suction strength) and cycle (suction speed) can be
adjusted independently of each other. Pressing the switches changes
the vacuum or the cycle by one level.
Turn on the pump by pressing the stand-by switch (Fig. 8). The
green LED display will light up. Choose the settings which you
find most comfortable.
Press the up-arrow to increase the vacuum (suction strength).
Press the down-arrow to reduce the vacuum (Fig. 9).
Press the up-arrow to step-up the cycle (suction speed). Press the
down-arrow to reduce the cycle (Fig. 10).
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Questions: visit www.ardo-usa.com or call us at 844-411-ARDO (2736)
5. 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 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 speed)
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 breast feeding. The following measures may be helpful:
Massage the breast before breast feeding.
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 increase milk production, and promote better flow.
Use a double pumpset
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.
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Questions: visit www.ardo-usa.com or call us at 844-411-ARDO (2736)
6. Troubleshooting / error indicator
In the event of an error, the LED display flashes green and orange alternately. There are three different error-displays:
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.
General error
(time-out)
Switch off the unit and re-start. If the error message appears again, the unit is
defective and cannot be repaired.
Voltage too low
Weak batteries
Incorrect or defective power adapter
Voltage too high
Incorrect or defective power adapter
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Questions: visit www.ardo-usa.com or call us at 844-411-ARDO (2736)
7. Maintenance / Care / Cleaning
The silicone 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.
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 10: Transport / Storage / Disposal).
Calypso is not waterproof. It complies with Standard IP21.
Pumpset: Please read the separate instructions for use, Section: Cleaning.
8. Warranty
For a period of one (1) year from the proven date of purchase or for a period of 400 hours of use (as long as the green LED
display lights up), whichever is later, (the “Warranty Period”), Ardo warrants to the original purchaser of the unit against
defects in material or workmanship. The purchase invoice serves as proof purchase and is the date on which the Warranty
Period will begin. The warranty is limited to the original purchaser. Repair or replacement under this limited warranty is
the sole and exclusive remedy of the original purchaser. Proof of purchase in the form of a receipted invoice or bill of sale
evidencing that the Product is within the warranty period must be presented to obtain warranty service. If the unit is repaired
or replaced under this Warranty, the Warranty Period will not be extended. The warranty will apply only if the instructions in
the User Instructions are followed and only if Ardo medical AG accessories used. This warranty is provided free of charge. It
does not affect any claims or legal or other rights of the customer under the applicable national laws governing the sale of
consumer products. For warranty service contact 844-411-ARDO (2736).
EXCEPT TO THE EXTENT PROHIBITED BY APPLICABLE LAW, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE ON THE PRODUCT IS HEREBY DISCLAIMED. ARDO SHALL NOT BE LIABLE FOR ANY INCIDEN-
TAL, CONSEQUENTIAL, SPECIAL OR PUNITIVE DAMAGES OF ANY KIND FOR BREACH OF THE EXPRESS LIMITED WARRANTY
ON THE PRODUCT OR ANY WARRANTY IMPLIED BY OPERATION OF LAW. OTHER THAN THE EXPRESS LIMITED WARRANTY
SET FORTH ABOVE, THERE ARE NO OTHER WARRANTIES THAT ACCOMPANY THIS PRODUCT AND ANY ORAL, WRITTEN OR
ANY OTHER REPRESENTATION OF ANY KIND IS HEREBY DISCLAIMED.
The warranty will be voided by: (1) unauthorized use or access to the unit; (2) if the unit has been opened; (3) improper
handling contrary to the instructions for use; and (4) if the unit has been repaired, altered or modified by an entity other
than Ardo. Nor does this warranty apply to unit defects or malfunctions caused by normal wear and tear, incorrect voltage,
accident, fire or other causes not attributable to Ardo.
NB
After 400 hours, the green LED display changes to orange. This means that the additional Guarantee has expired. The
Calypso can however still be used without any reduction in performance.
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Questions: visit www.ardo-usa.com or call us at 844-411-ARDO (2736)
9. Technical Information
9.2 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), UL1431, ANSI/AAMI
ES60601-1:2005, CSA C22.2 No. 68-09, CSA C22.2 No. 60601.1:2008
9.1 Technical data
Pump dimensions
190 x 130 x 76 mm Classification in accordance with MDD93/42 Class 2a
Power adapter dimensions 75 x 46 x 31 mm Power adapter input voltage
100 - 240 VAC ± 10 %
Pump weight
0.545 kg
Frequency
50 Hz / 60 Hz
Power adapter weight
0.150 kg
Regulated power adapter output
9 Vdc, 1.4 A
Double insulated protection class Class II
Vacuum range
50 - 330 mbar
Protection level
BF
Permitted tolerance of the vacuum strength ± 5 %
Life time (excluding normal wear
and tear)
800 hours Operating temperature
Relative humidity
41 °F to 104 °F
(+5 °C to +40 °C)
20 - 95 %
Transport and storage conditions
Temperature
41 °F to 104 °F (+5 °C to +40 °C)
Relative humidity
20 - 95 %
Air pressure
700 - 1060 hPa
10. 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).
Disposal
Properly dispose of the device in accordance with local, state and federal regulations.
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9.3 EMC Test records
See Page 10
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9.4 Key to symbols
Important information
Warning: General risk points – check with the
instructions for use
Please note instructions for use
Compliance with Directives MDD 93/42 EEC
Manufacturer
Unit type BF
The unit is subject to the stipulations of WEEE
Directive 2002/96/EC
Protection class II
IP21 drip-proof protection (Calypso)
IP20 drip-proof protection (power adapter)
Alternating current
Direct current
Temperature
Air pressure
Relative humidity
Fragile, handle with care
Keep packaging away from heat
Keep packaging away from moisture
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IP20
IP21
P
RH