medela 101046016_2024-02-b Contact Nipple Shields Instruction Manual

: June 1, 2024
: medela

Table of Contents

medela 101046016_2024-02-b Contact Nipple Shields
Intended purpose
Cleaning
Disinfection
How to use
References
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medela 101046016_2024-02-b Contact Nipple Shields

medela-101046016-2024-02-b-Contact-Nipple-Shields-
product

Please read all instructions before using this product. Keep these instructions for future reference.

Intended purpose

The Medela Contact Nipple Shields are intended to cover and protect the nipples of a mother to support breastfeeding.

Indications
The Contact Nipple Shields are indicated for use when the mother has flat or inverted nipples, sore nipples, or suffers from nipple pain. They can also be used when the baby has latch-on problems (such as an atypical sucking technique), when the baby does not transfer the milk well, or for preterm infants who fall asleep almost immediately at the breast.

Contraindications
There are no known contraindications.

Important safety information
For a patient/user/third party in the European Union and in countries with identical regulatory regimes (Regulation 2017/745/EU on Medical Devices); if, during the use of this device or as a result of its use, a serious incident has occurred, please report it to the manufacturer and/or its authorized representative and your national authority.

use the product only for its intended purpose as described in these instructions for use.
Use by more than one person without adequate reprocessing may be a health risk and could cause cross-contamination.
Use Medela’s original accessories only.
Do not use it if the packaging is open or damaged before first use.
Inspect before each use. Throw away at the first signs of damage or weakness.
Never leave packaging and components unattended. Keep them out of reach of children.
If problems or pain occur, consult your lactation consultant or physician.

Cleaning

Important

Only use drinking-quality water for cleaning.
Process the shield and the storage box before first use.
Clean all parts immediately after use.
The cleaning instructions below are general. For country-specific regulations and guidelines, ask your Medela agent or visit our website (www.medela.com).

Before first use and once a day

Cleaned the shield and the storage box as described under “After each use”.
Disinfect the shield and the storage box as described under “Disinfection”.

After each use

Rinse the parts with cold water (approx.20 °C). Clean the parts with plenty of warm, soapy water (approx.30 °C).
Use a commercially available washing-up liquid, preferably without artificial fragrances and coloring. Rinse parts with cold water (approx.20 °C).
Dry it with a clean cloth or leave it to dry on a clean cloth.

Disinfection

Clean the product as described under «Cleaning».
Cover the parts with water and boil for five minutes.
Alternatively, clean the parts in the dishwasher.
Place them on the top rack or in the cutlery section.
Use a commercially available dishwashing detergent.
Dry it with a clean cloth or leave it to dry on a clean cloth.

Storage

Put the clean nipple shield in the clean storage box, if available.
Alternatively, put the shield in a clean storage bag or a clean environment.
It is important that all residual moisture dries. Do not store in an airtight container/bag.

How to use

Wash your hands thoroughly with drinking-quality water and soap before touching the shield and the breast. Dry your hands with a fresh towel or a single-use paper towel.
Clean the breast and surrounding area with a damp cloth. Do not use soap or alcohol which can dry the skin and cause cracked nipples.
Moisten the shield with water as this will help it to stick to the skin (see Figure).
Push the tip almost inside out and grip the wings of the shield (see Figure 2).
Place the shield centrally over the nipple (see Figure 3). The open section should point in the direction of the baby’s nose during feeding.

Choosing the correct nipple shield size
When choosing the correct nipple shield size you need to consider both mother and baby.

For the mother
The shield should fit comfortably without pinching.

In the case of a premature infant
When grasping the shield, the infant’s lips must be able to reach the flat base of the shield against the breast.

Product variants
Available in 3 sizes: S/16mm, M/20mm or L/24mm.
Material nipple shield: Silicone
Material storage box: Polypropylene (PP)
Disposal: According to local regulations

Indicates conformity with the EU’s requirements for medical devices
Indicates the manufacturer (ISO 15223-1, 5.1.1 manufacturer)1
Indicates the date of manufacture (ISO 15223-1, 5.1.3 Manufacturing date)
Indicates that the packaging contains products intended to come in contact with food according to regulation (EC) No 1935/2004.
Keep away from sunlight (ISO 15223-1, 5.3.2 Keep away from sunlight)1
Fragile (ISO 15223-1, 5.3.1 Fragile, handle with care)1
Keep dry (ISO 15223-1, 5.3.4 Keep away from rain)1
Indicates that an item can technically be recycled (ISO 7000-1135)
Indicates that the material is part of a recovery/recycling process. Indicates that the package is made of cardboard.
Indicates the number of products included in the package.
Consult the instructions for use (ISO 15223-1, 5.4.3 Consult the instructions for use)
The Green Dot is a scheme in which participating bodies coordinate the collection, sorting, and recovery of used packaging.
ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labeling, and information to be supplied, Part 1: General requirements, Clause [refer back to symbol]
These symbols are not derived from standards.