ardo Wearable Double Electric Breast Pump Instruction Manual

Wearable Double Electric Breast Pump

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Specifications

• Brand: Ardo

• Model: Melia

• Type: Wearable Double Electric Breastpump

• Intended Use: Express and collect breast milk from lactating
  mother’s breast

• Package Contents: 2 pump motors, 2 breast shells, 2 breast
  shell inserts, 2 silicone diaphragms, 2 lip valves, 2 milk
  collectors, 2 bra adjustment buckles, 2 USB charging cables, 1
  instructions for use, 1 information sheet

Product Usage Instructions

1. Important Safety Information

Before using the Ardo Melia Electric Breastpump, please ensure
you read and understand the safety information provided in the user
manual to prevent any injuries or harm.

2. Assembly

CAUTIONS:

1. Attach the lip valve to the milk collector, paying attention to
   the direction of installation.

2. Insert the silicone diaphragm into the milk collector and press
   it firmly to ensure a perfect seal.

3. Align the breast shell with the milk collector slot and press
   firmly to secure the seal.

4. Attach the pump motor to the milk collector by aligning the
   notch with the silicone diaphragm and ensure a complete seal
   fit.

3. Operating Instructions

Refer to the LED display and button functionality section in the
manual to understand the symbols and buttons for different modes
and settings. Follow the instructions for stimulation mode,
expression mode, level adjustments, and pause/start
functionality.

4. Cleaning and Maintenance

After each use, disassemble the parts and clean them according
to the instructions provided. Ensure all components are completely
dry before reassembling. Regularly check for wear and tear and
replace any worn-out parts promptly.

5. Storage

Store the Ardo Melia Breastpump in a cool, dry place away from
direct sunlight. Keep it out of reach of children when not in
use.

Frequently Asked Questions (FAQ)

Q: Can I use the Ardo Melia Breastpump for multiple users?

A: No, the device is intended for a single user only to maintain
hygiene and prevent cross-contamination.

Q: How often should I replace the silicone diaphragms and lip

valves?

A: It is recommended to replace silicone diaphragms and lip
valves every 3-6 months or if you notice any signs of damage or
wear.

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ardo melia
wearable double electric breastpump
Instructions for use
Instruction Video

Thank you for choosing
Ardo

ardo melia

Electric Breastpump

Table of Content
1. Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 2. Conventions used in these instructions for use. . . . . . . . . . . . . . . . . . 4 3. Important safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 4. Product description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 5. Getting started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 6. Charging your Ardo Melia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 7. Tips for a successful pump session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 8. Cleaning, transfer and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 9. Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 10. Technical information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 11. Disposal information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 12. Symbols definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 13. Warranty specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Emission and immunity tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

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1. Overview
Thank you for purchasing this product. Breast milk is the best source of nutrition for babies in the first year as recommended by doctors, and it contains antibodies that help protect your baby from infections and allergies. You can express and store your breast milk by using a breastpump. That way, when you cannot breastfeed your baby (whether you’re away, resting, or returning to work or study), your baby can still enjoy the benefits of your breast milk. The Ardo Melia has a soft silicone breast shell and intuitive design to make the entire pumping session more comfortable and convenient. And, as the pump is easy to assemble and discreet, you can take it with you anywhere, allowing you to pump milk at your convenience and maintain your milk supply.
2. Conventions used in these instructions for use
WARNING. May lead to moderate injury.
CAUTION. May lead to minor injury.
NOTE. May lead to material injury.
TIPS. Useful or important information that is not related to safety.
Please read these instructions for use carefully before using your Ardo Melia and save them for future reference. Failure to follow these instructions and safety information may lead to injury from the Ardo Melia.
3. Important safety information
3.1 Indications for use The Ardo Melia electric breastpump is meant to express and collect breast milk from the lactating mother’s breast. The device is intended for a single user.
3.2 Safety precautions
WARNINGS
· Do not share the device with others. · Only use products or parts described in these instructions for use. · Close supervision is necessary when the Ardo Melia is used near children. · Do not modify the Ardo Melia yourself or attempt to open or repair the Ardo Melia or charger. · The Ardo Melia is not provided as sterile. Boil breast shell, breast shell insert, silicone diaphragm, lip valve, and milk
collector prior to first use and ensure that these parts are cooled sufficiently before being assembled. Do NOT wash or boil the pump motor. · Do not use harsh chemicals to clean breast shell, breast shell insert, silicone diaphragm, lip valve, and milk collector. · Do not put breast shell, breast shell insert, silicone diaphragm, lip valve and milk collector in microwave or microwave sterilizer bags. · Do not wash or immerse pump motor in water. Wipe it with clean, damp cloth only. · Do not place the Ardo Melia in refrigerator or freezer.
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· Do not store wet or damp components. Dry them thoroughly before storing. · Do not warm up breast milk in the microwave or in hot water. · Do not refreeze defrosted breast milk. · Plug charger into an electrical outlet that is visible and easily accessible. To remove main power cord, unplug the power
supply from the wall. · Do not operate the Ardo Melia if the power cord or plug is damaged or after having been submerged in water. · Do not drop or insert any object into any openings of the pump. · Do not use the Ardo Melia in an airplane. · Do not operate where aerosol spray products are used or oxygen is being administered. · The Ardo Melia will not work when connected to charger; always disconnect the Ardo Melia from charger before using. · Do not attempt to reset the Ardo Melia during use. · Consult your healthcare practitioner to understand how long you should pump in a pumping session before using the
Ardo Melia. · Pregnant women should not use the Ardo Melia, as pumping can induce contractions or premature labor. · If you are a mother who is infected with Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV), pumping
breast milk will not reduce or remove the risk of transmitting the virus to your baby through your breast milk.
3.3 Precautions · Ensure breast shell, breast shell insert, silicone diaphragm, lip valve and milk collector are clean. · Ensure breast shell, silicone diaphragm, lip valve and milk collector are securely assembled and connected to pump motor. · Before each use, visually inspect the individual components for cracks, chips, tears, discoloration, or deterioration. If damage to the Ardo Melia is observed, please discontinue use until the parts have been replaced. · If the Ardo Melia is stored at minimum temperature, please wait 2 hours before use to allow it to warm up to room temperature. · If the Ardo Melia is stored at maximum storage temperature, please wait 2 hours before use to allow it to cool down to room temperature. · If you feel discomfort, suction can be broken by inserting a finger between the breast and the breast shell. · If you feel irritation or discomfort, discontinue use and see a doctor. · If the power adapter casing or wiring becomes loose, separated, or frayed, stop using the power adapter immediately and contact the device manufacturer. · Stop using the Ardo Melia immediately if you notice any smoke or burning from the pump unit or power adapter. · If the package appears damaged or tampered with before use, do not use and contact the distributor of the Ardo Melia.
3.4 Contraindication No known contraindications.
3.5 Usage and operating life · The Ardo Melia is usable by a single user and has an expected operating life of 1 year. · Reusable parts (including breast shells, breast shell inserts, silicone diaphragms and lip valves) should be cleaned prior to use. Replacement of reusable parts is recommended every 3 months or whenever they appear damaged.
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4. Product description

4.1 Product structure diagram

a

b

c

d

a Breast shell b Pump motor c Silicone diaphragm d USB charging cable e Breast shell insert f Milk collector g Bra adjustment buckle h Lip valve

e

f

g

h

Note: Additional breast shell sizes / inserts and spare parts are available in online shops, and in some countries also from midwives, lactation consultants, pharmacies, or drugstores. For wholesale prices contact Ardo directly.

4.2 Description of LED display and button functionality

1

6

2

7

3

8

9

4

10

5

11

12

No.

Symbol / button name

1

Stimulation mode symbol

2

Expression mode symbol

3

Level down button

4

Level indicator

5

Pause/Start button

6

Function description When Stimulation mode selected When Expression mode selected Decrease suction level Indicates the suction level Switch between Pause and Work

No.

Symbol / button name

6

Auto mode symbol

7

Massage mode symbol

8

Level up button

9

Time unit

10

Battery indicator

11

Power button/Mode selection button

12

Timing indicator

Function description When Auto mode is selected When Massage mode selected Increase suction level Displays minutes Indicates battery status Power ON/OFF switch / Mode selector switch Indicate how long the pump is in use

4.3 Package content
2 pump motors; 2 breast shells; 2 breast shell inserts; 2 silicone diaphragms; 2 lip valves; 2 milk collectors; 2 bra adjustment buckles; 2 USB charging cables; 1 instructions for use, 1 information sheet.

5. Getting started
5.1 Assembly To assemble the Ardo Melia, follow the steps below.
CAUTIONS:
· Make sure that you clean the Ardo Melia as instructed in these instructions for use. · Make sure that you assemble the pump correctly as instructed in these instructions for use. · To avoid leakage, remove any residue around the rim before assembling. · Wash your hands thoroughly before assembling cleaned components.
1. Attach the lip valve to the milk collector. Pay attention to the direction of installation.

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2. Insert the silicone diaphragm into the milk collector and press it firmly to make the edges fasten tightly to ensure a perfect seal.

3. To install the breast shell on the milk collector, make sure to align the slot on the edge of the breast shell with the slot of the milk collector, and then press the edges with both hands to ensure that the seal is in place.
4. Attach the pump motor of the breastpump to the milk collector, align the notch under the main body with the silicone diaphragm, and assemble it downward to fit the milk collector to ensure a complete seal fit.

5. If necessary, adjust the size of the funnel using a breast shell insert or a different size of breast shell. Breast shells in size 24 mm and breast shell inserts in size 19 mm are included with the Ardo Melia. Breast shells in size 27 mm and breast shell inserts in size 17 mm are also available for this breastpump (we reserve the right to change this).

5.2 Pumping

5.2.1 · · · · · ·

Before pumping Wash your hands well with soap and water, and make sure your breasts are clean. Inspect the pump kit to make sure it is clean before every use. Clean pump, power switch, and countertop where you place the pump with disinfectant wipes. Make sure that you have a glass of water nearby. Gently squeeze a little milk from each nipple to make sure that milk ducts are not blocked. Relax in a comfortable chair, leaning slightly forward; if necessary use cushions for back support.

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5.2.2 To begin pumping 1. Press the breast shell firmly against the breast, leave no gaps, and make sure your nipples are centered inside the breast shell. Keep the Ardo Melia upright. Be careful not to change the position of the Ardo Melia on the breast; otherwise it will not have suction.
2. Press and hold the power button to start the Ardo Melia; the screen lights up. (The font colour of the display is light in contrast to that on the picture on the front page of this booklet. A dark font colour was chosen on the picture for better visibility).
3. To start or pause the Ardo Melia, press the ” ” button. 4. The starting working mode of the Ardo Melia is Expression mode with suction level of one. 5. Press the ” ” button shortly to switch between the 4 working modes: Stimulation mode, Expression mode, Massage
mode, and Auto mode. · The ” ” symbol lights up indicating that the Ardo Melia is currently in Expression mode. · The ” ” symbol lights up indicating that the Ardo Melia is currently in Stimulation mode. · The ” ” symbol lights up indicating that the Ardo Melia is currently in Auto mode. · The ” ” symbol lights up indicating that the Ardo Melia is currently in Massage mode.
6. When switched to Auto mode, the Ardo Melia will start from the first suction level of Auto mode by default, increase by one suction level every 15 seconds, until the 12th suction level, and stay at the 12th suction level to continue working. If you press the “+” “or “-” button during this process, it will change to manual mode and stay in the corresponding suction levels to work. At this point, you can increase/decrease the suction levels by pressing the “+” level up button or “-” level down button. 9

7. There are 15 levels in each mode. You can choose the suction that makes you comfortable by briefly pressing the “+” level up and “-” level down button.
8. You can pause or continue the breastpump operation by briefly pressing the ” ” button. 9. Press and hold the power button ” ” to turn off the breastpump.
CAUTIONS: 1. The Ardo Melia has a built-in memory function: When you turn on the Ardo Melia again, the device automatically enters
and up shifts to the working mode and suction levels you used last time. If the Ardo Melia is turned on for the first time, the working mode is Expression mode with suction level one. 2. The suction level is not memorized in Auto mode (Auto mode has the default suction level one). When the Ardo Melia is in Auto mode and no other button is pressed, the suction level will be automatically increased in steps of 15 seconds until it reaches level 12. If you press a button during this period, the automatic increase in suction stops. 3. After the device is paused, and no button is pressed within 5 minutes, the Ardo Melia will automatically shut down. 4. The maximum duration of a pump session is 20 minutes, after which the Ardo Melia will automatically shut down. It can then be turned on again if you need to continue your pump session. TIPS: · Do not worry if your milk does not flow immediately. Relax and continue pumping. The first few times you use the Ardo Melia, you may need to use a higher suction level in Expression mode to get your milk flowing. · When needed, you can also use Stimulation mode, Massage mode, or Automatic mode to start expressing. During expression, you can switch to Stimulation mode, Expression mode, Massage mode, or Automatic mode by briefly pressing the power button/mode selection button for better pumping results. · Not all suction levels need to be used. You can use the level that makes you comfortable. · Stop pumping when the amount of milk in the milk collector reaches 6 o.z. (180 ml ). Pour the breast milk into a bottle to prevent overflow. · You can use the included bra adjustment buckles to lengthen the straps of your nursing bra during pumping. This will give your bra enough room to hold the breast milk collector.
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WARNINGS The Ardo Melia cannot work while charging. 5.3 Ending your pumping session
1. When you finished your pumping session, press and hold the power button to switch off your Ardo Melia. Remove the Ardo Melia from your breast.
2. Separate the pump motor from the milk collector.
3. Pour the milk into the milk storage bottle or milk bag; make sure the pouring slot is aligned with the bottle or the bag.
4. Clean the washable parts according to the cleaning instructions in chapter 8. TIPS:
· Do not continue pumping for more than 5 minutes at a time if you do not succeed in expressing any milk. Try again later. · If you experience extreme discomfort or pain while using the Ardo Melia, stop using it and consult your breastfeeding
consultant. · Never tilt the Ardo Melia when the milk has reached the maximum line on the milk collector to avoid spillage. Pour the
milk into a milk container (bottle or bag) before continuing to pump. · After pumping, take off the milk collector from the pump motor immediately, and then pour the milk into the milk bottle
or bag for sealing and storage.
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6. Charging your Ardo Melia
6.1 Charge the Ardo Melia Check the battery indicator after each use by pressing the power button. If the battery indicator blinks, charge the Ardo Melia with an Ardo recommended charger.
Charging port Type C

1. Plug charger into pump’s USB-C charge port. 2. Plug the wall charger into a standard electrical outlet. 3. Once pump motor is charged, remove charger from pump and unplug the charger from the electrical outlet.

6.2 Battery status indicator illustration Battery status indicator displayed Third bar is always on One bar flashing

Remaining pump time left No less than 100 minutes No less than 5 minutes

6.3 Charging times Full charge takes approximately 120 minutes (2 hours). The power indicator will light 3 bars and will stop blinking when fully charged.
TIPS:
· The Ardo Melia contains a rechargeable lithium battery and can be used without the adapter connected. The Ardo Melia cannot be operated while charging.
· The Ardo Melia has a 3-bar battery indicator. When the power is off or the charger is not connected, the battery indicator DOES NOT light up.
· When the power is off and the charger is connected, the battery indicator lights up. While charging, the battery indicator blinks. After charging is finished, the three bars will stop blinking and will be steady.
· When the Ardo Melia is being operated and the charger is not connected, the battery indicator will indicate the battery level. The last bar will only start blinking if the battery level is low.
· When the Ardo Melia is being operated and the charger is connected, the pump will stop operation and begin charging in order to protect the device.
WARNINGS
Only use the certified DC5V1A adaptor recommended by us, that meets the requirements of the IEC 60950 standard.

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7. Tips for a successful pump session
The Ardo Melia is easy to use. After some practice you will soon get used to comfortably express milk.
· Choose a time when you are not rushed or easily interrupted. · Having your baby or a photograph of your baby nearby increases the level of the “happiness hormone” Oxytocin which
can help improve your milk flow. · Before pumping, place a warm towel on your breast and use light stimulation for a few minutes. This encourages milk
flow and helps avoid pain. · Warmth and relaxation can encourage milk flow. Try pumping after a warm bath or shower. · Try expressing from one breast while you breastfeed on the other; or continue expressing after breastfeeding your baby. · Repositioning the pump on the breast from time to time can help stimulate your milk flow.

8. Cleaning, transfer and storage

8.1 Cleaning and maintenance

First time use

After each use

Pump’s housing (pump motor)

Turn on Ardo Melia by pressing power button.

Wipe with a clean damp cloth with 70% ethyl alcohol or isopropyl alcohol as needed. Do not immerse pump motor in water.

Breast shell, breast shell insert, silicone diaphragm, lip valve, milk collector

Boiling in water for 10 minutes. Do not microwave breast shell, breast shell insert, silicone diaphragm, lip valve and milk collector.

Clean with mild dish washing liquid and clean water.

WARNINGS
· Be careful when removing and cleaning the lip valve, if the lip valve is damaged, the Ardo Melia will not work properly. · To clean the lip valve, please rub it gently in the warm water with a few drops of dish washing liquid. Do not insert any
objects into the lip valve, which may cause damage.
8.1.1 Clean by hand · Place pump parts in a clean wash basin used only for infant feeding items. Do not place pump parts directly in the sink. · Add soap and hot water to wash basin. · Scrub items using a clean brush used only for infant feeding items. · Rinse by holding items under running water, or by submerging in fresh water in a separate wash basin. · Air-dry thoroughly. Place pump parts, wash basin, and brush on a clean, unused dish towel or paper towel in an area protected from dirt and dust. Do not use a dish towel to rub or pat items dry. · Clean wash basin and brush. Rinse them well and allow them to air-dry after each use. Wash basin and bottle brush by hand or in a dishwasher at least every few days.

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8.1.2 ·
·

Clean in dishwasher If you decide to clean pump parts in a dishwasher, be sure to place small items into a closed-top basket or mesh laundry bag. Add soap and if possible, run the dishwasher using hot water and a heated drying cycle.
Remove from dishwasher with clean hands. If items are not completely dry, place items on a clean, unused dish towel or paper towel to air-dry thoroughly before storing. Do not use a dish towel to rub or pat items dry.

8.1.3 Disinfection Breast shell, breast shell insert, silicone diaphragm, lip valve, milk collector, and other parts which come into contact with breast/ breast milk should be disinfected by boiling in water for 10 minutes as follows:
· Separate all parts that come in contact with breast/breast milk. Wash hands thoroughly. · Fill pot with enough water to cover all parts, bring water to a boil. Place parts in boiling water for 10 minutes. · Allow water to cool and gently remove parts from water with tongs. · Place parts on a clean surface and/or towel. · Allow all parts to air dry. · Store dry parts in a clean, cool place when not in use. Do NOT store wet or damp parts.

TIPS:

· Breast shell, breast shell insert, silicone diaphragm, lip valve and milk collector are dishwasher safe using top rack only. WARNINGS

· Do not wash pump motor. Wipe with clean, damp cloth, if needed. · Do not use harsh chemicals to clean breast shell, breast shell insert, silicone diaphragm, lip valve, and the milk collector.
Rather use dish washing liquid. · Do not store wet or damp parts.
8.2 Milk storage guidelines
Storing expressed milk 1. Use breast milk storage bags or clean food-grade containers with tight fitting lids. Avoid plastic containing bisphenol A
(BPA) (recycle symbol #7). 2. Write the date of pumping on the storage container; include your child’s name, if you are giving the milk to a child care
provider. 3. Gently swirl the container to mix the creamy part of the breast milk that may rise to the top back into the rest of the
milk. Do not shake the milk. This can cause some of the milk’s valuable ingredients to break down. 4. Refrigerate or chill milk right after it is pumped, if possible. You can put it in the refrigerator, place it in a cooler, or
insulated cooler pack, or freeze it in small (2- to 4-ounce) batches for later feedings. Pumped milk is OK without being refrigerated for up to 4 hours after pumping.

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Type of breast milk

Human milk storage guidelines

Countertop
77 ºF (25 ºC) or colder (room temperature)

Refrigerator 40 ºF (4 ºC)

Freshly expressed or pumped Up to 4 hours

Up to 4 days

Defrosted, previously frozen 1-2 hours

Up to 1 day (24 hours)

Leftover from a feeding (baby did not finish the bottle)

Use within 2 hours after the baby is finished feeding

Freezer 0 ºF (-18 ºC) or colder
Within 6 months is best, up to 12 months is acceptable
Never refreeze human milk after it has been defrosted

NOTE: · Store milk in the back of the freezer or refrigerator, not on the door shelve. · When freezing, leave an inch of space at the top of the container; breast milk expands when it freezes. · Milk can be stored in an insulated cooler bag with frozen ice packs for up to 24 hours when you are travelling. · If you don’t plan to use freshly expressed milk within 4 days, freeze it right away.

9. Troubleshooting
This chapter summarizes the most common problems you could encounter with the Ardo Melia. If you are unable to solve the problem with the information below, please contact the local customer service center (in the USA: support@ardo- usa.com).

Problem Lack of suction

To solve issues
Check that all components are assembled correctly and that the lip valve is positioned correctly.
Make sure that the diaphragm and the lip valve are fitted securely to the pump body and a perfect seal is created.
The air pressure in your region is too low (high altitude), this may affect the suction.
Make sure the pump is assembled correctly, and the suction is created.

No milk being expressed

Relax and try again, as expression may improve with practice.

Pain in the breast area when expressing Leakage of breast milk during use

Refer to the section “Tips for a successful pump session”.
You may be pumping at too high suction level. You do not need to use the highest suction; instead use suction level that is still comfortable. Press the level-down button to lower the suction intensity.
Consult your health professional / breast feeding adviser.
Remove and refit the breast shell. Make sure that it is installed correctly and firmly.
Try leaning slightly forward.

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10. Technical information
10.1 Specifications

Power requirements

• Only use the charger recommended as below:

Power supply Charger specifications

Charging power: 5Vdc by wall adaptor Operating power: 3.7Vdc Li-Ion battery
Input: 100-240 Vac, 50-60 Hz, 0.4 A-0.2 A Output: DC5 V, 1 A

Technology specifications

Use environment

Home or office use

Prescription necessary

No; over-the-counter and retail sale

Pump dimensions

123 mm × 110 mm × 69 mm

Package dimensions

264 mm × 155 mm × 109 mm

Weight

249 g (per each pump)

Milk collector capacity

180 ml (6 fl.oz.)

Single/Multiple user device

Single user device (personal breastpump)

Provided non-sterile

Yes

Re-usable

Yes

Pump options

Single per each pump

Pump type

Diaphragm pump

Vacuum range1 (Stimulation)

40­170 mmHg

Vacuum range1 (Expression)

120­260 mmHg

Vacuum range1 (Massage)

40­140 mmHg

Vacuum range1 (Auto)

40­260 mmHg

Cycle speed (Stimulation mode)

77­127 cycles/minute

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Cycle speed (Expression mode)

32­92 cycles/minute

Cycle speed (Massage mode)

79­143 cycles/minute

Cycle speed (Auto mode)

32­136 cycles/minute

Adjustable suction levels

15 levels

Visual indicator

LED screen

Auto-off time

Automatically turn-off after 20 minutes

Service Life

1 year

1Accuracy of the vacuum range: +/- 3 %. The vacuum values are depending on the actual atmospheric pressure.

10.2 Operating conditions Operating temperature Relative humidity Atmospheric pressure

41­104 °F (5­40 ºC) 15 %­ 90 %; non-condensing 90 KPa ­ 106 KPa

10.3 Transport and storage Transport and storage temperature Relative humidity Atmospheric pressure

-4 °F­ 140 °F (-20­ 60ºC) 15 %­ 90 %; non-condensing 70 KPa­ 106 KPa

10.4 EMC Declaration The Ardo Melia may be used at home, in the office, or in other general areas. Special consideration should be given to the following use:
· During medical procedures: Do not use the Ardo Melia during any medical procedure or during imaging. For example, do not use the Ardo Melia during RF ablation of a skin anomaly, x-ray, MRI, or ultrasound.
· With other equipment: Use of the Ardo Melia adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, the Ardo Melia and the other equipment should be observed to verify that they are operating normally.

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· In high electrostatic discharge environments: If the air is very dry, use the Ardo Melia where floors are wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. If you notice shocks when you touch things, as sometimes happens in very dry winter months, be sure to touch a metal item such as a table before handling the Ardo Melia.
· In industrial settings: Avoid using the Ardo Melia near arc welding equipment, radar installations, and similar industrial settings.
· Near RF emitters: Keep devices that use WiFi, Bluetooth, and other international RF emitters at least 30 cm from the Ardo Melia during operation. This includes communications equipment peripherals such as antenna cables and external antennas. Otherwise, degradation of the performance of the Ardo Melia could result. If you know the power output the RF emitter, the table labeled “Electromagnetic Compatibility Compliance Statement Information” can be used for more precise information about separation distances.
WARNINGS
Use of accessories other than those specified by Ardo medical may result in increased emissions or decreased immunity of the Ardo Melia. The Ardo Melia complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
1. The Ardo Melia may not cause harmful interference; 2. The Ardo Melia must accept any interference received, including interference that may cause undesired operation.
NOTE
The Ardo Melia has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC rules.
10.4.1 Electromagnetic compatibility The Ardo Melia 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 20).
11. Disposal information
The Ardo Melia contains a rechargeable lithium-ion battery. Use your local return and collection system for electrical waste and electronic equipment (including batteries). Breast shell, breast shell insert, silicone diaphragm and lip valve should be disposed of in your home’s waste management container.
WARNINGS
· The Ardo Melia should not be used in the vicinity or on the top of other electronic equipment such as cell phone, transceiver or radio control products. If you need to do so, the Ardo Melia should be observed to verify normal operation.
· The use of accessories and power cord other than those specified (with the exception of cables sold by the manufacturer of the equipment or system as replacement parts for internal components) may result in increased emissions or decreased immunity of the equipment or system.
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12. Symbols definition
The warning symbol identifies all instructions that are important for safety. Failure to observe these instructions can lead to injury or damage to the Ardo Melia! When used in conjunction with the following words, the warning symbol stands for:
12.1 Pump control buttons

Button symbol

Function description ON/OFF or Mode selection Level down = decrease suction level Level up = increase suction level Pause/Start

12.2 Symbols on the packing

Symbol

Definition This symbol indicates to keep the device dry.
This symbol indicates to keep the device away from sunlight.
This symbol indicates the temperature limitation for operation, transport and storage.
This symbol indicates the humidity limitation for operation, transport and storage. This symbol indicates the atmospheric pressure limitation for operation, transport and storage. This symbol indicates to follow instructions for use. This symbol indicates that the packaging contains products intended to come in contact with food according to regulation 1935/2004.

12.3 Symbols on the device

Symbol

Definition
This symbol indicates to follow instructions for use.
This symbol indicates do not dispose the device together with unsorted municipal waste (for EU only).
This symbol indicates a type BF applied part.

19

This symbol indicates the degree of IP protection. This symbol indicates the date of manufacture (four digits for the year and two digits for the month). This symbol indicates manufacture’s serial number of the device.
This symbol indicates direct current.

13. Warranty specification
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.
13.1 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.

Emission and immunity tests

Electromagnetic emissions Guidance and manufacturer’s declaration ­ electromagnetic emissions

Emissions test

Compliance

RF emissions, CISPR 11

Group 1

RF emissions, CISPR 11

Class B

Harmonic emissions, IEC 61000-3-2

Not applicable

Voltage fluctuations/ flicker emissions, IEC 61000-3-3

Not applicable

20

Guidance and manufacturer’s declaration ­ electromagnetic immunity

Immunity test
Electrostatic discharge (ESD), IEC 61000-4-2

IEC 60601-1-2 Test level
±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air

Compliance level
±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air

Electrical fast transient/burst, IEC 61000-4-4

Not applicable

Not applicable

Surge, IEC 61000-4-5

Not applicable

Not applicable

Voltage dips, short interruptions, and voltage variations on power supply input lines, IEC 61000-4-11
Power frequency magnetic field, IEC 61000-4-8

Not applicable 30 A/m, 50Hz/60Hz

Not applicable 30 A/m, 50Hz/60Hz

Conducted RF, IEC61000-4-6

Not applicable

Radiated RF, IEC61000-4-3

10 V/m 80 MHz ­ 2,7 GHz 80 % AM at 2 Hz

NOTE: UT is the AC mains voltage prior to application of the test level.

Not applicable
10 V/m 80 MHz ­ 2,7 GHz 80 % AM at 2 Hz

Guidance and manufacturer’s declaration ­ electromagnetic immunity

Radiated RF
IEC610004-3
(Test specifications for ENCLOSURE PORT IMMUNITY to
RF wireless communications equipment)

Test Frequency (MHz)
385
450
710 745 780

Band (MHz) 380­390
430­470
704 ­787

Service
TETRA 400
GMRS 460, FRS 460
LTE Band 13, 17

Modula- Maximum Distance

tion

Power (W) (m)

Pulse

modula- 1,8

0.3

tion 18 Hz

FM ± 5

kHz deviation

2

0.3

1 kHz sine

Pulse

modulation

0,2

0.3

217 Hz

IEC 60601-1-2 Test Level (V/m)

Compliance level (V/m)

27

27

28

28

9

9

21

Radiated RF
IEC610004-3
(Test specifications for ENCLOSURE PORT IMMUNITY to
RF wireless communications equipment)

Test Frequency (MHz) 810
870
930
1720
1845

Band (MHz)
800­960
1700­ 1990

1970

Service

Modulation

GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5

Pulse modulation 18 Hz

GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS

Pulse modulation 217 Hz

Maximum Distance Power (W) (m)

2

0.3

2

0.3

IEC 60601-1-2 Test Level (V/m)

Compliance level (V/m)

28

28

28

28

2450

2400­ 2570

Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7

Pulse modulation 217 Hz

2

0.3

28

28

5240 5500

5100­ 5800

WLAN 802.11 a/n

Pulse modulation

0,2

0.3

9

9

5785

217 Hz

22

Distributed by:
Ardo medical AG Gewerbestrasse 19 6314 Unterägeri Switzerland
www.ardomedical.com

Distributor USA:
Ardo medical, Inc. 13800 Coppermine Road 1st Floor Herndon, VA 20171, USA
844-411-ARDO (2736) support@ardo-usa.com www.ardo-usa.com

99.04.561 / V01 / 05.2024

References

• USA Location information - USA.com
• Ardo Home Page - Ardo: Supporting Pregnancy, Birth, & Breastfeeding
• Ardo products for breastfeeding, pregnancy and childbirth

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