BiliCocoon Nest and Bag System Instructions for Use Ver 13 Oct 2017

Instructions for use: BiliCocoon™ Disposable

EN

NeoMedLight 88-90 rue Frédéric Faÿs 69100 VILLEURBANNE, FRANCE

November 2018

User Responsibility These Instructions for Use describe the proper setup and use of the BiliCocoon™ Disposable – the “Disposable” or the “Product”. The Product is to be used with the BiliCocoon™ Phototherapy System1: the combination of the two of them is referred as “Device” in this document. The Product is to be used exclusively by a properly trained user and should not be used if it is damaged, contaminated, or if parts are missing: Instead, please dispose of it and replace it. The user is solely responsible for the risks to the patient, clinicians, third parties or properties or for a treatment with inadequate performances due to an improper use or modifications made on the Product. Any serious incident which occurs in relation to the device should be reported to the manufacturer and the local competent authority of the state in which the user and/or patient is established. You can contact NeoMedLight at the following address: quality@neomedlight.com. According the US federal law this Product sale is restricted to licensed medical practitioners or clinicians or under their approval.

NeoMedLight declares that this Product complies with the European Directive 93/42/EEC. The CE mark was obtained in 2016.

1 Also mentioned as “BiliCocoon™ System”

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Instructions for use: BiliCocoon™ Disposable

EN

1. PRODUCT DESCRIPTION AND APPLICATION A. Description The BiliCocoon™ Disposable is a single-use product intended to be used exclusively with the BiliCocoon™ System, a phototherapy system for treatment of unconjugated hyperbilirubinemia in the infant. The BiliCocoon™ System consists of a light emitting Pad connected to a Light Box which emits light in the absorption spectrum of bilirubin, thus reducing the bilirubin concentration in the body of infants. For more information, see the BiliCocoon™ System Instructions for Use. The BiliCocoon™ Disposable is a single-use medical device intended to be used on one patient only, thus protecting the newborn against cross-contamination. Two sorts of Disposables are available: -

The BiliCocoon™ Nest Disposable is to be used with the BiliCocoon™ Nest System

-

The BiliCocoon™ Bag Disposable is to be used with the BiliCocoon™ Bag System

For more information, see “3. Technical Features”.

B. Intended use of the Device The BiliCocoonTM Phototherapy System is intended for the treatment of unconjugated hyperbilirubinemia2 in the population of neonates and infants under 3 months old and weighing less than 10kg. It can be used in the clinical setting or in the home.

C. Additional information -

Only for the treatment of unconjugated hyperbilirubinemia, which is responsible for the majority of cases of neonatal jaundice.

-

Only with medical prescription

-

Only for the duration indicated in the treatment protocol

-

Target patient population: neonates and infants 3.

-

Over the patient's entire body except for genitals and eyes – eye protection must be worn.

-

To be used with a single patient

-

To be used in hospital or at home: adapted to different environments for use (in an incubator, on a table, in a cradle, in the arms of a parent or caregiver).

-

Not to be used on damaged skin

2 The Device is not designed to treat cholestatic jaundice. 3 Under 3 months old and weighing less than 10 kg – definition according to EN 60601-2-50. The term “infant” used in this

document is used in compliance with this definition according to EN 60601-2-50.

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Instructions for use: BiliCocoon™ Disposable

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2. SAFETY INFORMATION Types of safety precautions Warning It informs of a danger or a hazard for the infant or the operator.

Important It mentions the actions required to obtain the expected clinical results. Prerequisites The Device must only be used by clinicians who are qualified and aware of the device- and treatmentassociated risks and benefits; or by laypersons who are properly trained and supervised by these clinicians

Warning

Home Use: The home user must be trained before the first use of the Device about its setup and use and become aware of the device-associated risks. The home user must follow the recommendations and instructions contained in the instructions for use – concerning the System and the Disposable – and provided by clinicians The Device is not to be used for other medical indications or on different body parts than those recommended. Improper use may lead to an ineffective treatment (i.e. no benefits) or to potential risks to the patient's health (e.g. adverse events). Keep out of the reach of children.

Warning

Duration of Session: Warning

Use the system only for the time prescribed. A use that does not take into account the treatment plan may lead to an ineffective treatment or to potential risks to the patient's health. Intensive phototherapy (>30 μW∙cm-2∙nm-1) may not be adapted to all infants (e.g. preterm infants with a weight ≤1000 g)

Warning

Contraindications The Device must not be used:

Warning

-

On patients with congenital porphyria

-

On patients with family history of porphyria

-

In conjunction with drugs or agents that are photosensitizers

-

On patients requiring a sterile environment or equipment and/or who present with skin lesions.

A use that does not take into account these contraindications may lead to an ineffective treatment (i.e. no benefits) or to potential risks to the patient's health (e.g. adverse events). Eye Protection

Warning

Prolonged exposure to phototherapy light can cause damage to the eyes. The use of the BiliCocoon™ Photherapy System without suitable protection of the infant’s eyes may lead to risks for the infant’s health, including retinal damage. Eye protection should be used for other patients who are close to the phototherapy device. Patient monitoring during the phototherapy treatment -

Warning

Bilirubin level: The infant’s bilirubin level should be regularly measured during the phototherapy treatment in accordance with the recommendations of the physician in charge.

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Instructions for use: BiliCocoon™ Disposable

Warning

EN

-

Temperature: Phototherapy can affect the patient’s body temperature. The infant’s temperature must be monitored according to the recommendations of the physician who is responsible for the therapy. Because the phototherapy treatment may increase the body temperature, not monitoring the infant’s temperature may lead to a risk to the patient.

-

Fluid balance: Phototherapy can affect the patient’s fluid balance. Regularly monitor the patient’s fluid balance and take appropriate measures to maintain this balance during phototherapy.

Side Effects for Caregivers and People near the Phototherapy System Prolonged exposure to the phototherapy device’s blue light may cause discomfort to caregivers such as eye irritation, nausea, headaches or dizziness. Caregivers, staff and others who are in close proximity to the Device could be sensitive to blue light and need to protect their eyes. Cutaneous Reactions Cutaneous eruptions such as erythema may occur in infants treated with phototherapy.

Warning

Skin Color Changes Blue light may hinder clinical observations by masking skin color changes, such as cyanosis. Warning

Rare Allergic Reactions Warning

Despite the biocompatibility evaluation tests conducted in accordance with the state of the art, rare allergic reactions may nevertheless occur. Cross Contamination: The Pad is to be used in combination with its specific Disposable. The infant should not be placed in direct contact with the Pad. The Disposable is not designed for re-use and should not be cleaned, disinfected, or placed in contact with the cleaning products used to clean the Pad. Not using the Disposable or having the cleaning products in contact with the infant may lead to allergic reactions for the infant.

Warning

The BiliCocoon™ Disposable is not intended to be used with a phototherapy treatment system other than the BiliCocoon™. The Disposable is a single use, single-patient medical device. It should be used respecting the usual hygiene precautions and only use this single-use device for one patient. There is indeed a crosscontamination risk if the Disposable is used for more than one patient. Disposable may be used multiples times on the same over a period of 24 hours. However, the user must make sure that the Disposable is neither damaged nor soiled between each use Variation of the Ambient Conditions

Warning

Variations of the ambient conditions (room temperature and humidity, sun exposure, nearby devices) may unfavorably affect the patient’s health, including their temperature or their fluid balance. Moreover, use of this Device outside of the given operating conditions may compromise its functionality. Reflective Foils

Warning

Never use reflective foils to increase the effectiveness of phototherapy treatment, it may hazardously increase the body temperature.

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Instructions for use: BiliCocoon™ Disposable

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Flammability Warning

Keep away from flame, sparks and other ignition sources. No modification of the Disposable is allowed.

Warning

The use of a Product which has been modified disregarding the manufacturer’s indications may lead to risks to the patient (e.g. adverse events), the user, other peoples or properties. Positionning Do not place the infant inside the Disposable

Warning

For all the phototherapy-related risks refer to the BiliCocoon™ System Instructions for Use. Labels Integrity and Readability

Warning

In case labels are degraded, the information addressing the safety of the patient, users, third parties, and properties can be found in this document. If the product cannot be identified by its label because the latter is damaged, please use another item.

Symbol

Description

Symbol

Description

Manufacturer

CE Marking declaration according to Directive 93/42/EEC

Consult instructions for use

Date of manufacture

Catalogue number

Batch code

Protect infants' eyes with opaque eye protection

Do not re-use

Do not use if the package is damaged

Non-sterile

Absence of Latex

Operating temperatures limits and storage temperature limits for products out of the box

Storage temperatures limits for Products in the original box

Keep away from sunlight

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Instructions for use: BiliCocoon™ Disposable

Keep dry

EN

Position of the infant in the Nest Disposable

Position of the infant in the Bag Disposable

Abbreviations and Units Abbreviations

Units and Description

°C

Degree Celsius

(Unit of Temperature)

kg m hPa

Kilogram Meter Hectopascal

(Unit of Mass) (Unit of length) (Unit of atmospheric pressure)

3. TECHNICAL FEATURES The BiliCocoon™ Disposable is a non-woven medical device intended to be used exclusively with the BiliCocoon™ Pad, in order to keep the phototherapy system clean during treatment (see the BiliCocoon™ System Instructions for Use) and provide a comfortable interface between the skin of the baby and the Pad. The BiliCocoon™ is a single-use product, intended to be used for one patient only and to prevent cross contaminations. -

The BiliCocoon™ Nest Disposable is to be used with the BiliCocoon™ Nest System

-

The BiliCocoon™ Bag Disposable is to be used with the BiliCocoon™ Bag System

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Instructions for use: BiliCocoon™ Disposable

BiliCocoon™ Nest Pad

BiliCocoon™ Bag Pad

1.

Lighting Surface

1.

Lighting Surfaces

2.

Cable

2.

Cable

3.

Connection

3.

Connection

•

Nest Disposable Front view Contact with the patient

•

EN

Back view

Bag Disposable

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Instructions for use: BiliCocoon™ Disposable

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Use & Storage (For Products out of the box) Conditions

Warning

Temperature

10°C – 35°C4

Relative humidity

15% – 90% without condensation

Atmospheric pressure

700 – 1060 hPa5

Others

Indoor use & storage only

Disregarding the operating and storage conditions may lead to the Product deterioration, therefore creating risks for the patient, the users, third parties or properties

4 Equivalent to 50-95°F

5 Equivalent altitude: 0 – 3000 m / 0 – 9842,52ft

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Instructions for use: BiliCocoon™ Disposable

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4. INSTALLATION AND USE A. Preliminary Precautions Important

Select the Disposable according to the Pad type (Nest Pad or Bag Pad). Before inserting the Pad in the Disposable, check the Pad mean irradiance as described in the protocol contained in the BiliCocoon™ System Instructions for Use.

Warning

If the device is not verified before each use, there is a risk of under-exposure – leading to an ineffective treatment – or of over-exposure.

Warning

Make sure that the enclosure of the BiliCocoon™ Pad is neither dirty nor broken, and that there are no sharp edges that might cause an injury. Clean the Pad before each use as described in the BiliCocoon™ System Instructions for Use.

Warning

Ensure that the Pad is clean and dry. The BiliCocoon™ Disposable should not come in contact with the detergents used to clean the Pad.

Warning

Never place the infant directly on the Pad. Always use the Disposable specifically designed for the BiliCocoon™ System. Infants should wear a diaper during the phototherapy session.

Warning

Warning

Check that the packaging of the BiliCocoon™ Disposable is not damaged: The use of a Product whose cleanliness is intended as a main feature and controlled thereof, but whose packaging is damaged, may lead to a risk for the patient's health.

Warning

Check that the Disposable is clean and not damaged. The use of a Disposable that is damaged or contaminated, use of the incorrect disposable, or the use of the BiliCocoon™ System without Disposable may lead to an inadequate treatment or to risk for the patient.

Warning

Warning

Ensure that the fastening tabs, their adhesion surfaces, the Pad fixing tabs, and the Infant fastening system are intact. The phototherapy system may increase the patient’s body temperature when it is used in combination with a thermotherapy system (e.g. infant incubators, infant transport incubators, infant radiant warmers, devices supplying heat via blankets, pads or mattresses). In this case, the user should measure the infant’s body temperature directly (i.e. on the skin’s surface) and use the baby controlled mode of these devices, otherwise the set air temperature of the incubator or the heater output of the radiant warmer or heated mattress has to be adjusted according to the body temperature measurements. Place the Light Box outside of these systems.

B. Setup of the Disposable and Positioning of the Infant

Never use the BiliCocoon™ System without the associated Disposable. Warning

Important We recommend not to use the Bag System for babies weighing less than 2500g IFU-BCC-DI-EnFr-2018-12-v09

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Instructions for use: BiliCocoon™ Disposable

•

EN

For the BiliCocoon™ Nest Disposable

Front View

Back View

1. Soft part

4. Back face

2. Strap used to keep the Pad bent over the newborn

5. Side tab

3. Insertion slit of the Pad

6. Adhesion band The side tab (5) is meant to be fixed to the adhesion band (6)

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Instructions for use: BiliCocoon™ Disposable

1. Place the BiliCocoon™ Disposable on a flat surface with the soft part (1) facing the user.

EN

2. Insert the Pad in the Disposable through the insertion slit (3) so that: - the Disposable completely covers the Pad - The Pad Lighting Surface (the one with the label) is immediately under the aforementioned soft part (1)

Bend the Pad along the direction of the optical fibers (as in the picture) easily. Warning 3. Check that this soft part (1) is in contact with the Pad Lighting Surface. The Lighting Surface is not to be placed in contact with the Disposable’s back face (4).

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Important Disposable.

to insert it more

4. Check that the Pad is fully inserted to the edge of the BiliCocoon™

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Instructions for use: BiliCocoon™ Disposable

Warning 5. After the Pad has been correctly inserted into the BiliCocoon™ Disposable, check that the Disposable has not been damaged during the insertion. A damaged Disposable may lead to an inadequate treatment or a risk to the patient

EN

7. Place the infant on the Disposable with the baby’s legs towards the Pad cable.

Warning 6. The infant must wear a diaper during treatment. Place the diaper trying to maximize the skin surface area which is in contact with the Lighting Surface.

Warning Never place the infant’s head close to the Pad cable. This may otherwise lead to an ineffective treatment or to a risk of strangulation for the patient

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Instructions for use: BiliCocoon™ Disposable

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9. The user may keep the BiliCocoon™ Nest Pad sides bent over the infant through the Warning

8. Protect infant eyes with suitable eye protection.

appropriate strap (2). Fix the side tab (5) on the adhesion band (6). This disposition let the blue light come from the sides with a larger body surface which is exposed.

10. Start the treatment

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Instructions for use: BiliCocoon™ Disposable

•

EN

For the BiliCocoon™ Bag Disposable

Folded Bag Disposable

Unfolded Bag Disposable

Infant Fastening system

1. Front part with the patterned adhesion surface

4. Lateral flaps with fastening tabs

7. Side tabs

2. Insertion slits (x2) for the two Pad Lighting Surfaces

5. Shoulder fastening tabs

8. Ventral flap

6. Infant fastening system

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Instructions for use: BiliCocoon™ Disposable

1. Place the BiliCocoon™ Disposable on a flat surface

2. Place the Disposable on a table as in the picture, i.e. with the front part (1) facing the user when the Disposable is folded.

EN

3. Insert the Pad Lighting Surface with the label in the insertion slit below (indicated by the arrow in the picture).

Warning: Never place the Pad Lighting Surface with the label in the insertion slit of the Bag Disposable's front part. Disregarding this instruction may lead to a patient with the respiratory tract constricted.

4. Insert the second Pad Lighting Surface in the front part insertion slit (indicated by the arrow in the picture).

The Pad’s Lighting Surfaces should be completely covered by the Disposable and should be in contact with the soft inner surface of the BiliCocoon™ Disposable.

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Important 5. Check that the two Pad’s Lighting Surfaces are fully inserted to the edge of the BiliCocoon™ Disposable.

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Instructions for use: BiliCocoon™ Disposable

6. Cross and secure the Pad fixing tabs (3) so that the Pad cannot slip out of the Disposable

Warning It is important to cross these tabs as shown in the picture on the right prior to placing the infant in the Disposable.

9. Place the infant on the Disposable, using the neckline cut-out as a reference to adjust his/her position.

EN

7. Unfold the disposable and its infant fastening system (6).

Warning 8. After the Pad has been correctly inserted in the Disposable, check that the Disposable has not been damaged during the insertion. A damaged Disposable may lead to an inadequate treatment or to a risk to the patient.

11. Place the ventral flap (8) between the infant’s legs and fold it on his/her stomach. Attach the side tabs (7) on the ventral flap (8).

Warning The infant must wear a diaper. Place the diaper trying to maximize the skin surface area which is in contact with the Lighting Surface.

10. Check that the infant is in contact with the Disposable inner surfaces (soft face).

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Important 12. If the ventral flap (8) is too long, fold it in order to have the stomach exposed and to maximize the body surface area that will be treated.

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Instructions for use: BiliCocoon™ Disposable

Important 13. Check that the infant is properly positioned and securely fastened in the Disposable.

EN

15. Position the shoulder fastening tabs (5) on the patterned adhesion surface (1). This will prevent light emission outside of the Disposable.

14. Fold the front part (1) on the infant chest so that the patterned adhesion surface faces the user.

Warning: Make sure that the infant’s head is outside of the Bag.

16. Fold the lateral flaps (4) to wrap the infant and prevent light emission outside of the Disposable. Place the fastening tabs of the lateral flaps (4) on the patterned adhesion surface (1).

Warning: Be careful not to bother the respiratory tract. It is important not to cross the fastening tabs.

Warning

17. Protect the Infant’s eyes with suitable eye protection.

18. Start the treatment.

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Instructions for use: BiliCocoon™ Disposable

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NB: For a more comfortable treatment, it is possible to open the upper corners and let the infant’s arms pass through them.

NB: A Disposable can be reused – on the same patient exclusively – after the end of the session and over a period of 24 hours only if it’s clean and undamaged. Between uses, fold the Velcro adhesive tabs on themselves to preserve their adhesiveness.

C. Session settings Refer to the BiliCocoon™ System Instructions for Use.

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Instructions for use: BiliCocoon™ Disposable

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D. Disposal of the BiliCocoon™ Disposable

Warning

Warning

The BiliCocoon™ Disposable may be soiled during a phototherapy session. It must be disposed of according to local practices for contaminated products. Contaminated products are to be disposed of separately from consumer waste. Contaminated products may otherwise harm people and pollute the environment.

The BiliCocoon™ Disposable is not to be gas-sterilized or autoclaved.

5. PRODUCT CATALOG NUMBERS BCC010

BiliCocoon™ Light Box

BCC101

BiliCocoon™ Nest System

BCC111

BiliCocoon™ Nest Pad

BCC12150

BiliCocoon™ Nest Disposable x50

BCC201

BiliCocoon™ Bag System

BCC211

BiliCocoon™ Bag Pad

BCC22150

BiliCocoon™ Bag Disposable x50

BCC301

BiliCocoon™ Fixation System

6. STANDARDS AND GUIDELINES EN ISO 10993-1 EN 60602-50

EN ISO 10993-5 Directive 93/42/EEC

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EN ISO 10993-10 REACH Regulation 1907/2006

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