ardo 63.00.242 Calypso Electric Breast Pump Instruction Manual

: June 5, 2024
: ardo

Table of Contents

Product description
Important safety details
Intended use
Start-up / Operation
Pumping
Troubleshooting
Maintenance / Care / Cleaning
Warranty
Technical Information
Transport / Storage / Disposal
Test Report
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

ardo 63.00.242 Calypso Electric Breast Pump Instruction Manual

Thank you for choosing the gentle Calypso breastpump from Ardo.

In these instructions you will find important and useful details which will make your Calypso experience even more rewarding.

Product description

a Calypso breastpump
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

Product description

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

| Important information
---|---
| Please follow instructions for use
| Compliance with Directive 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)

IP21 protected against fingers or similar objects

| IP20 not protected against water (power adapter) IP20 protected against fingers or similar objects
| Alternating current
---|---
| Direct current
| Temperature
| Air pressure
| Relative humidity
| Fragile, handle with care
| Keep packaging away from heat
| Keep packaging away from moisture
| Instructions for use

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.

Preparing the pump for use

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).

Connecting the pumpset

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).

Operation

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 breast feeding. 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

Technical data

(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, EN 60601-1-2, EN ISO 10079-1, EN 60601-1-6, EN 60601-1-11, 2011/65/EU (RoHS)

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)

EMC Test records

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

Test Report

Summary of test for Electromagnetic Compatibility

The test of electromagnetic compatibility according to IEC / EN 60601-1-2 for the Calypso breastpump has shown that in the intended use no endangering of the functional safety or a failure of the breastpump due to electromagnetic influences are to be expected.
The breastpump uses RF-energy exclusively for its internal function. Its RF- 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.

The Calypso breastpump should not be operated at a short distance from other equipment. Do not place any other equipment on the breastpump housing.
If it must operate at a short distance from other equipment, the equipment should be observed to verify its proper function.
Mobile radio equipment or mobile phones should not be used at a short distance from the breastpump or its mains power cable.
Interference may occur in the vicinity of equipment marked with the symbol opposite

Manufacturer’s declaration – Electromagnetic Emissions and Immunity

Electromagnetic Compatibility (EMC, IEC 60601-1-2, Table 1)

Electromagnetic Emissions

Calypso is intended for use in the electromagnetic environment specified below.

The customer or the user of Calypso should assure that it is used in such environment.

Emission Tests| Compliance level| Electromagnetic environment – guidance
RF emissions CISPR 11| Group 1| Calypso uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference with nearby electronic equipment.
RF emissions CISPR 11| Class B| Calypso is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies build- ings used for domestic purposes.
Harmonic emissions IEC 61000-3-2| Class A
Voltage fluctuations / flicker emissions

IEC 61000-3-3

| Complies

Electromagnetic Compatibility (EMC, IEC 60601-1-2, Table 2)

Electromagnetic Immunity

Calypso is intended for use in the electromagnetic environment specified below.

The customer or the user of Calypso should assure that it is used in such environment.

Immunity Tests| IEC 60601 test level| Compliance level| Electromagnetic environment

– guidance

Electrostatic Discharge (ESD) IEC 61000-4-2| ± 6kV contact

± 8kV air

| ± 6kV contact

± 8kV air

| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burst IEC 61000-4-4| ± 2kV

for power supply lines

± 1kV

for input / output lines

| ± 2kV

for power supply lines

n/a

| Mains power quality should be that of a typical commercial or hospital environment.

Surge

IEC 61000-4-5

| ± 1kV

line(s) to line(s)

± 2kV

line(s) to earth

| ± 1kV

line(s) to line(s)

n/a

| Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

| < 5% UT

(> 95% dip in UT) for 0.5 cycle

| < 5% UT

(> 95% dip in UT) for 0.5 cycle

| Mains power quality should be that of a typical commercial or hospital environment.

If the user of Calypso requires continued operation during power mains interruptions, it is recommended that Calypso be powered from an uninterruptible power supply or a battery.

40% UT

(60% dip in UT) for 5 cycles

| 40% UT

(60% dip in UT) for 5 cycles

70% UT

(30% dip in UT) for 25 cycles

| 70% UT

(30% dip in UT) for 25 cycles

< 5% UT

(> 95% dip in UT) for 5 sec

| < 5% UT

(> 95% dip in UT) for 5 sec

Power frequency magnetic field IEC 61000-4-8| 3A/m| >30A/m| Power frequency magnetic fields should be at levels of a typical commercial or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.

Electromagnetic Compatibility (EMC, IEC 60601-1-2, Table 4)

Electromagnetic Immunity

Calypso is intended for use in the electromagnetic environment specified below.

The customer or the user of Calypso should assure that it is used in such environment.

Immunity Tests| IEC 60601

test level

| Compliance level| Electromagnetic environment – guidance
| | | Portable and mobile RF communications equipment should be used no closer to any part of Calypso , including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d=[3.5/U1] √P d=[3.5/E1] √P

for 80MHz to 800MHz d=[7/E1] √P

for 800MHz to 2.5GHz

where P is the maximum output power rating of the transmitter in watts [W] according to the transmitter manufacturer and d is the recommended separation distance in meters [m].
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compli- ance level in each frequency range b.

Interference may occur in the vicinity of equipment marked with the following symbol:

Conducted RF IEC 61000-4-6| 3Vrms

150KHz-80MHz

| [U1] V = 10Vrms
Radiated RF IEC 61000-4-3| 3V/m

80MHz-2.5GHz

| [E1] V/m =

10V/m

| |
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a Field strength from fixed transmitters, such as base stations for radio telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromag- netic environment due to fixed RF transmitters, and electromagnetic site survey should be considered. If the measured field strength in the location in which the Calypso is used exceeds the applicable RF compliance level above, the Calypso should be observed to verify normal operation. If abnormal performance is observed, additional measures may be neces- sary, such as re-orienting or relocating the Calypso.
b Over the frequency range 150KHz to 80MHz, field strength should be less than 3V/m.

Electromagnetic Compatibility (EMC, IEC 60601-1-2, Table 6)

Recommended separation distance between portable and mobile RF communications equipment and Calypso

Calypso is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The cus- tomer or the user of Calypso can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and Calypso as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter

[W]

| Separation distance according to frequency of transmitter [m]
| 150kHz to 80MHz| 80MHz to 800MHz| 800MHz to 2.5GHz
| | |
0.01| 0.04| 0.04| 0.07
0.1| 0.11| 0.11| 0.22
1| 0.35| 0.35| 0.7
10| 1.11| 1.11| 2.21
100| 3.5| 3.5| 7
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters [m] can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts [W] according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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)

Ardo medical AG
Gewerbestrasse 19
6314 Unterägeri
Switzerland
T +41(0)41 754 70 70
F +41(0)41 754 70 71
info@ardo.ch
www.ardomedical.com

E358823 0123 Class IIa