ardo Alyssa Electric Breastpump Instruction Manual

ardo Alyssa Electric Breastpump

Thank you for choosing the Ardo Alyssa breastpump.

Breast Shell Sizes

The breast shell size is correct if:

• the nipple moves freely in the funnel and can follow the rhythmic movements of the breastpump.
• no part, or very little, of the areola is in the funnel.
• the milk flows and the breast feels uniformly soft after expression.

Product description

Ardo Alyssa breastpump
Ardo pumpset (included accessory)
Connection opening for pumpset
Power adapter with USB cable
Connection opening for USB power adapter
Bottle stand for pumpset

Ardo Alyssa is a vacuum pump to extract breast milk and is intended for personal use in both the home and work environment. It expresses in two phases (stimulation and expression modes) that imitate the sucking behaviour of the baby. With
Ardo Alyssa you can express milk from one breast or both breasts at the same time.
The German text is the reference for the contents.

Instructions for the accessories: Only use Ardo pumpsets. Breast shells are available in the sizes ø 22 / 26 / 28 / 31 and 36 mm (see accompanying instructions for use for ‘Pumpset and accessories’). Which breast shell sizes are included with delivery of your Alyssa is indicated on the packaging.

Control elements and symbols

The illustrations of the control elements and symbols are located on the fold out page of the cover. The active elements or symbols light up.

| On/Off button (standby button)| Switches the breastpump on and off
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| Memory Plus button| Tap the Memory Plus button: Saves the expression history of a pumping session.
Memory Plus button lights up: Sequence is saved but is not displayed.
Memory Plus button flashes: Saved expression history is displayed.
| Power Pumping button| Automatically starts the Power Pumping program (interval pumping over an hour).
The different segments light up green (during expressing) or white (during the pauses) depending on the progress of the interval pumping.
| Bluetooth®| Shows the connection to the breastpump via Bluetooth
| Battery display| Shows the charge level of the rechargeable battery
| Vacuum display| Step indicator for vacuum (suction level)
| Cycle display| Step indicator for cycle (suction frequency)
| Vacuum buttons| Increase or decrease the vacuum (suction level)
| Cycle buttons| Increase or decrease the cycle (suction frequency)
| Mode button| Displays the current mode and enables manual switching between stimulation and expression modes
| Stimulation mode| Upper semicircle lights up orange in stimulation mode
| Expression mode| Lower semicircle lights up green in expression mode
| Timer| Displays the expressing time

Important safety information and warnings

Ardo Alyssa is an electrically operated, safe and reliable medical device. It has been developed and is manufactured according to CE guidelines and the relevant safety standards. For your safety and to prevent damage to the device and to avoid the risk of electric shock, injury or fire, please follow the safety instructions below.

READ THE INSTRUCTIONS FOR USE COMPLETELY BEFORE USING THIS BREASTPUMP.
Not following these instructions for use may lead to damage to the device or personal injury

KEEP THESE INSTRUCTIONS FOR USE.
For help with the initial setup or if something unexpected happens, please contact the point of sale or the customer service team at the manufacturer Ardo medical AG.

Information for the user
According to Regulation (EU) 2017/745 on medical devices, any serious incidents that occur in connection with the product must be reported to the manufacturer and the competent authorities of the Member State in which the user resides.

Risk due to contamination / infection

• To prevent contamination of your breast milk, thoroughly wash your hands with soap and water before each use.
• Only use original Ardo pumpsets. If parts from other manufacturers are used, there is a risk of microbial contamination of parts as well as the breast milk because the parts are not compatible.

Risk of health problems and serious injuries

• This device must not be used during pregnancy because expressing breast milk can start contractions.
• Do not use this device while driving a car (even as a passenger).
• Do not use this breastpump if you are overtired and may fall asleep during use, because this may lead to irritation of the nipples.
• Make sure that this device is not used unsupervised by children or by people with reduced mental capabilities.

Ardo Alyssa may only be used for the purposes described in Section 3. For all uses apart from the intended use, all warranty and liability claims against the manufacturer are excluded.

Risk of an electric shock

• The Ardo Alyssa breastpump with the power adapter is only suitable for use indoors. Do not use outdoors.

• Only use this breastpump with the supplied Ardo original USB cable and power adapter.

• Ensure that the power adapter can always be easily accessed.

• Ardo Alyssa is not waterproof.
  – The device must therefore not be immersed in water or other liquids nor used or stored in locations where it could fall into water.
  – Do not use in the bath or when showering.
  – Do not clean in the dishwasher, under running water or by immersing in water.
  – The pump unit must not be used if it has fallen into water or is wet. If this happens, contact your service partner or the manufacturer!

• This breastpump must not be opened or modified in any way without the permission of the manufacturer. It does not contain any parts that are maintained by the user. For all uses apart from the intended use, all warranty and liability claims against the manufacturer are excluded.

• Handle this device with care and avoid all shocks, blows or vibrations (e.g. do not allow it to drop onto the floor). If this device is nevertheless exposed to one of the mechanical effects described above, carefully inspect the device for damage before the next use. If the device is damaged, contact the point of sale or the customer service team at Ardo medical AG.

Risk of fire or toxic vapors
Keep the pump unit, USB cable with power adapter and accessories away from sources of heat.

Risk of damage to the device or an unwanted change in the vacuum
Do not insert or suck up any objects or liquids into the tube connector port of the device.

Risk of injury due to the vacuum generated by the device or strangulation
Make sure that the device is not used unsupervised by children or by people with reduced mental capabilities.

Risk of incorrect mode of operation and reduction of the performance characteristics

• Using this device near other devices or stacked with other devices should be avoided.
• Portable and mobile RF communication equipment (radio devices including their accessories such as antenna cables and external antennas) should not be used at a distance less than 30 cm (or 12 inches) from the parts and cords of the device labeled by the manufacturer.
• The use of accessories, power adapters and cords other than those defined or provided by the manufacturer of this device may result in increased electromagnetic noise emissions or a reduced electromagnetic immunity for the device and lead to a faulty mode of operation.

Intended use

The Ardo Alyssa electric breastpump is used to express and collect breast milk from lactating or breastfeeding women by generating a defined vacuum at the breast. It can be used for single or double pumping. The breastpump is intended for use indoors. The Ardo Alyssa breastpump is intended for a single user.
The breastpump also enables mothers to empty the breast in cases of engorgement and breast inflammation and for sore nipples as well as for women with flat or inverted nipples. Ardo Alyssa is a medical device and is made up of the following parts: Pump unit and the pumpset accessory.

Operation and expressing

You can find more information about operating and using Ardo Alyssa at www.ardomedical.com.
If you need additional help, please contact the point of sale, customer service representatives or a lactation consultant or midwife.

Terms used

2-phase breastpump| Ardo Alyssa expresses in two phases: the stimulation and the expression modes, which imitate the sucking behaviour of the baby. This means a rapid cycle (suction frequency) with low vacuum (suction level) to stimulate the let-down reflex and a high vacuum with a slow cycle for efficient suction.
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Stimulation mode| A rapid cycle (suction frequency) and low vacuum (suction level) start the breast milk flowing or trigger the let-down reflex.
Expression mode| Slower cycle (suction frequency) and high comfortable vacuum (suction level) for efficient expressing of breast milk once the let-down reflex has been triggered.
Cycles| Suction frequency / suction speed
Vacuum| Suction strength
Single pumping| Expressing from one breast
Double pumping| Expressing from both breasts
Let-down reflex| A reflex that starts the breast milk flowing.
Memory Plus| Saves the personal expression history incl. settings and time in stimulation and expression mode. When the breastpump is next switched on, the saved expression history starts.
Power Pumping| Interval pumping over one hour to increase the breast milk volume
‘Vacuum Seal’ technology| Closed pump system with hygiene barrier in the breast shell itself.

Start-up

| WARNING: Risk due to contamination / infection
To prevent contamination of your breast milk, thoroughly wash your hands with soap and water before each use.
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You can operate the Ardo Alyssa with either the USB cable that is included or the integrated rechargeable battery

Mains operation
Push the flap backwards, insert the USB cable into the USB port on the breastpump and connect the power adapter to the mains power supply.

Battery operation
It is not necessary to fully charge the rechargeable battery before the first use.
You can connect Ardo Alyssa with the USB power adapter and charge the rechargeable battery during the first five hours of use at the same time (see Section 5).

Operation with a smartphone

The MyArdo app allows you to operate the Ardo Alyssa breastpump and to automatically save your expressing data.
Using the Memory Plus function, personal expression histories can be saved and accessed at any time using the MyArdo app.

Installing the MyArdo app

• Download the MyArdo app free of charge from the App Store or Google Play on your mobile device and install it.
  MyArdo app is available for both iOS and Android operating systems.

• Open the MyArdo app on your mobile device and confirm the query about the instructions for use.

Connect to the Ardo Alyssa breastpump

1. Ensure that Bluetooth is activated on your mobile device.
2. Switch the breastpump on.
3. The serial number or code requested on the screen is located on the bottom of the Ardo Alyssa.
4. When the breastpump is connected with Bluetooth, the corresponding symbol lights up .
5. Follow the instructions on the screen.

Preparing the Ardo Alyssa breastpump

Connecting the pumpset

Single pumping
Attach the tube connector to the Ardo Alyssa.
The second opening of the tube connector stays closed.

Double pumping
Open the second opening of the tube connector and connect the tube of the second pumpset. Connect the tube connector to the Ardo Alyssa.

The use of the pumpset is described in the enclosed instructions for use for the ‘Pumpset and accessories’.

Visual inspection before each use

Every time you use the breastpump, check that …
… the USB cable and the power adapter are undamaged.
… the pumpset is clean, correctly assembled and intact.
… the pumpset is correctly connected.

Operation and procedure for expressing

| Warning: Risk due to contamination / infection
To prevent contamination of your breast milk, thoroughly wash your hands with soap and water before each use.
---|---

Basic functions – step-by-step procedure

| Find a comfortable position for expressing, hold the pumpset on the breast shell and centre the nipple.
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| Gently tap the On/Off button to start expressing.
| The breastpump is in stimulation mode.
This can be seen by the upper segment of the mode button that lights up orange.|
| Adjust the vacuum (suction level) and the cycle (suction frequency) to what is comfortable for you. The vacuum and the cycle can be increased using the button or decreased using the button. By holding the particular button down, the intensity of the vacuum or cycle is changed by one step or one bar.
| After two minutes, the stimulation mode switches automatically to the expression mode .
a) If the breast milk starts to flow earlier, slowly tap the mode . button to manually switch to the expression mode.
b) If the let-down reflex could not be triggered after the preset two minutes, tap the mode button to extend the stimulation phase by another two minutes.
| The breastpump is in expression mode.
This can be seen by the lower segment of the mode button that lights up green.|
| Adjust the vacuum (suction level) and the cycle (suction frequency) to what is comfortable for you.
The vacuum and the cycle can be increased using the button or decreased using the button. By slowly tapping the corresponding button, the intensity of the vacuum or cycle is changed by one step or one bar.
Expressing is most successful if you select the vacuum and cycle settings that are comfortable for you.
| The timer starts automatically when the Ardo Alyssa is switched on and continuously displays the expressing time.|
| Massage the breast while expressing. This increases the volume of milk expressed.
| By holding down the On/Off button you can switch off the breastpump.

Silent Start

If the Ardo Alyssa is switched on and is not connected to a pumpset, it runs very quietly but does not pump. This silent start enables you to connect to the MyArdo app without the Ardo Alyssa being active.
When the pumpset is inserted, you can start to express (see Section 4.5).

Memory function – Individual expressing at the touch of a button

You have found your ideal settings when your breast milk flows freely and you can express most successfully. Activating the memory button saves your expression history. When you next switch the breastpump on, you can automatically express using the saved expression history in the stimulation mode and then in expression mode. The Ardo Alyssa breastpump stops automatically after the saved time.
You can nevertheless change the values for the vacuum and cycle manually at any time and define a new time for the length of the expression history. This takes you out of save mode. When you have finished expressing, you can save any changes to the expression history. If you do not save the new values, the previous settings are kept.
Whenever the Memory Plus button lights up, your expression history is saved, and when the breastpump is switched on, it automatically starts to pump with your individual data.

Using the Memory Plus function – step-by-step procedure

| Expressing
Express using your favorite settings.
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| Saving an expression history
When you are finished expressing, tap on the Memory Plus button to save your individual expression history. As confirmation, you will hear an acoustic signal, the button lights up and the breastpump automatically switches off.
| Accessing your expression history
Switch the breastpump on. You express directly with your saved data. The Memory Plus button flashes slowly throughout.

Deleting data
You can delete the saved data at any time if you do not want to express with the memory function. By slowly pressing the Memory Plus button once, the saved data are deleted and the button no longer lights up.

Power Pumping – Increasing the milk volume

Automatic Power Pumping is a pre-defined one-hour interval pumping program – expressing three times with two pauses – that aims to increase the volume of milk you produce. During the pauses you can remove the pumpset and move around freely.
The operation corresponds to the basic functions (see Section 4.5.1). The progress of the expressing is indicated by the green and white segments that light up.
Power Pumping imitates the natural sucking behavior of babies. There are times – usually in the evenings – when newborns or older babies want to be breastfed at 10-minute intervals to stimulate milk production (cluster feeding). More information can be found in Section 7.4.

Power Pumping use – Step-by-step procedure

| Expressing
Switch the breastpump on and press the Power Pumping button.
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| First expressing phase
The first segment of the button starts to light up green and the breastpump starts in stimulation mode. You can adjust the vacuum and the cycle to what is comfortable for you. After two minutes, Ardo Alyssa switches to the expression mode. Again, you can select the vacuum and cycle that work for you. The color of the mode button tells you which mode the breastpump is in.
| First pause
After 20 minutes a tone sounds and the first 10 minute pause starts. The second segment of the button lights up white. At the end of the pause, a reminder signal sounds.
You then have 5 minutes to activate the Power Pumping button and to continue expressing (during this time, the segments flash and a regular beep is emitted). Otherwise, the breastpump switches off.
| Second expressing phase
Ardo Alyssa expresses for 10 minutes. The settings for vacuum and cycle from the first expressing phase are used automatically. However, you can adjust these values at any time to suit your needs.
| Second pause
After 10 minutes a tone sounds and the second pause starts (see first pause for the sequence).
| Third expressing phase
The settings for vacuum and cycle from the second expressing phase are used. However, you can adjust these values at any time to suit your needs. After 10 minutes the Power Pumping stops and Ardo Alyssa switches off automatically.

The time indicator counts down the specified time in each phase.

Battery operation

• The breastpump has a built-in rechargeable battery. The battery cannot be replaced. The rechargeable battery is automatically charged when the supplied power adapter is connected to the mains power. The charging time is about 2 hours.
• If the device is operated while the battery is charging, the charging time is extended. Only use the power adapter and the USB cable that are supplied with the breastpump.
• It is not necessary to fully charge the rechargeable battery before the first use. The device can be operated with mains power and the rechargeable battery will be charged at the same time during the first 5 hours of use.
• You can express about 8 times with a fully charged battery.
• Air travel: The Ardo Alyssa has a lithium ion rechargeable battery. Please check if there are national restrictions on carrying lithium ion batteries when flying.

Charging the rechargeable battery
Insert the USB power adapter into the breastpump and connect it to the mains power.
When charging, the indicator moves from left to right until the battery is fully charged and the three bars light up white.
If the last bar of the battery symbol lights up red, the breastpump needs to be recharged soon.

Cleaning / maintenance

Cleaning Ardo Alyssa
Disconnect the breastpump from the mains power before cleaning. Wipe the device as needed with a damp cloth and normal dishwashing liquid. Please follow the safety instructions in Section 2.

Cleaning the pumpset
The cleaning instructions for the pumpset are described in the enclosed instructions for use for the “Pumpset and accessories”.

Maintaining Ardo Alyssa
The breastpump does not have to be serviced.

Useful tips for expressing

Triggering the let-down reflex

The let-down reflex may occur later when expressing than when breastfeeding. The following measures may help the breast milk to flow in addition to the stimulation mode:

• Relax and think about your baby.
• Look at a video or photo of your baby.
• Massage the breast before expressing.
• Extend the stimulation mode (see Section 4.5.1).
• Place a warm compress on the breast before expressing.

Comfortable settings for vacuum and cycle

What determines the level of the vacuum is your personal well-being and not the maximum vacuum that can be set.
Therefore, express using your comfortable vacuum setting. This will help you to express more breast milk, your breast milk will flow better and your nipples will remain intact.

Combination of massage and expressing

When you massage the breast while using the breastpump, this can increase your milk production and improve the milk flow.

Increasing the milk volume – Power Pumping

Use the unique automatic Power Pumping function of the Ardo Alyssa over one hour (see Section 4.7)

• Express from both breasts at the same time if possible. Double pumping increases the milk volume.

• Use the special bra for double pumping or take an old bra and cut out a hole for the breast shells.

• Use the 10 minute pauses to relax, drink a little, eat something, have a shower, read a book, listen to some music, do small chores around the house and so on.

• Use the Power Pumping 1–2 times a day.

• It may be that in the first few days you can only express a few drops.
  Don’t worry about this and persevere with the Power Pumping. By regularly stimulating your breasts, the milk volume will increase. It may take 3–4 days or even longer until the volume of breast milk increases.

• The expressed breast milk only has to be placed in the refrigerator at the end of the Power Pumping.

Pain when expressing

Expressing must not be painful. If it hurts, the following possible reasons must be eliminated:

• The vacuum is set too high. Adjust the settings so that they are comfortable for you (see Section 7.2).

• The nipples are not centered. Ensure that your nipples are in the middle of the breast shell.

• The funnel of the breast shell does not fit. It is too small or too big. The breast shell size is right if:
  – your nipples move freely in the funnel and follow the rhythmic movements of the breastpump (about 3 mm space between funnel and nipple).
  – none or only a little bit of the areola is located in the funnel.
  – the breast milk flows and the breast feels soft all over after the expressing.

• The breastpump is switched on before attaching the breast shell. As a result, the nipple is difficult to centre.

Order the correct size breast shell from Ardo, your specialist retailer or your qualified consultant. Ardo has the following breast shell sizes in stock: ø 22 / 26 / 28 / 31 and 36 mm (see fold-out page).

Troubleshooting

The breastpump suction is too weak or absent

• Ensure that the pumpset has been correctly assembled and is not damaged (see instructions for use for the ‘Pumpset and accessories’).
• Check that the pumpset is tightly attached to the breastpump.
• Check whether the USB cable and the power adapter are correctly attached and connected to the power supply.

If these steps still do not help you, please contact your point of sale, your retailer or the customer service team at Ardo.

Spare parts

Warranty

There are legally prescribed minimum warranty periods from the date of purchase that are specific for each country. The warranty coverage is limited to the first purchaser.

General terms and conditions

Ardo medical AG guarantees that their products are free from material and manufacturing defects. The warranty period starts from the date of purchase. Faulty materials are replaced free of charge during the warranty period, provided that the warranty has not been voided by improper use or interventions on the device. In order to safeguard the warranty coverage and ensure perfect functioning of the device, the instructions for use must be followed and only Ardo accessories may be used.
The warranty is voided if the device is opened or manipulated in any way

Technical information / symbols

Technical data

Pump unit

Vacuum pump type| moderate vacuum, low flow rate
Vacuum range at 0–2000 MAMSL| 30–330 mbar
Weight| 320 g
Battery capacity| 2600 mAh
Dimensions| 128 × 94 × 67 mm
Protection class| Class II
Applied part| Class BF
BLE radio frequency band| 2.4 GHz ISM
IP protection class| IP 22 (protected against solid objects of up to 12 mm and protected against falling water droplets if the housing is tilted at up to 15°)
Life time of device incl. power adapter| 400 hours
Operating conditions| +5°C to +40°C
10% to 93% RH
700–1060 hPa
Storage and transport conditions| -10°C to +60°C
10% to 93% RH
700–1060 hPa
Power adapter

Input voltage| 100–240 V, 50/60 Hz, max. 0.5 A
Output voltage| 5 V / 2.0 A (2.1 A)
Max. cable length| 1.5 m
IP protection class| IPX0 (no protection against solid objects or water
Approved models| EU: MKC-0502000VEUU (#99.05.025)
EU: XY-0030A (#99.05.025)
UK: MKC-0502000VUKU (#99.05.026)
UK: XY-0030AUK (#99.05.026)
US: MKC-0502000VU (#99.05.027)
US: XY-0030A (#99.05.027)
AU: MKC-0502000VAUU (#99.05.028)
AU: XY-0030AAU (#99.05.028)
CN: MKC-0502000XXX (#99.05.029)
CN: XY-0030ACN (#99.05.029)
KR: MKC-0502000XXX (#99.05.030)
KR: XY-0030AKC (#99.05.030)
| Safety instructions / warnings
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| Read and follow the instructions for use
| Compliance with valid European regulations for medical devices
| Manufacturer
| Device with applied part BF
| The device is subject to the provisions of the WEEE Directive 2002/96/EC
| Protection class
| Setting for the vacuum (suction level)
| Medical device
| Alternating current
| Direct current
| Temperature
| Air pressure
| Relative humidity
| Store protected from sunlight
| Keep the packaging away from moisture
| Setting for the cycles (suction frequency)
| Device corresponds to the requirements (Part 15) of the Federal Communications Commission (FCC)
| 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)

Disposal

The device can be returned to the manufacturer or be dismantled and recycled in an environmentally responsible manner by a recycling company specialising in electric devices. There are no special or increased risk factors. Waste must be disposed of in compliance with local regulations.

Electromagnetic compatibility

The Ardo Alyssa breastpump meets all the relevant requirements for the applicable standards relating to interference emissions and immunity for operation in medical and domestic environments.
More information about electromagnetic tests is given in the section ‘Emission and Immunity Tests’ (page 78).

Ardo medical AG
Gewerbestrasse 19 6314 Unterägeri Switzerland

T +41 41 754 70 70
F +41 41 754 70 71
info@ardo.ch
www.ardomedical.com

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