INSTRUCTIONS FOR USE Eyenovia MicroDose Dispenser ......2020/08/01 · PN-16492 Rev. A MicroPine Instructions For Use Page 3 of 12 INSTRUCTIONS FOR USE MicroDose Dispenser (MiDD)

PN-16492 Rev. A MicroPine Instructions For Use Page 1 of 12

INSTRUCTIONS FOR USE

Eyenovia MicroDose Dispenser (MiDD)

FOR STUDY PARTICIPANTS

• Mist the study medicine in each eye every night about 1 hour before bedtime. Use the instructions provided in this booklet.

• Keep study kits (including used MiDD cartridges) and packaging. You will need to bring your MiDD and these kits to the clinic when you return for scheduled visits.

- DO NOT discard any of the MiDD cartridge packaging.

Save trays and boxes to store used cartridges, then put them back in your Study Treatment Kit.

- DO NOT discard used MiDD cartridges or the MiDD base.

Who to Contact with Questions about your MiDD

Study Coordinator Name: ___________________________________________

Phone Number: ___________________________________________________

Email: __________________________________________________________

Caution: New Drug-Limited by Federal (United States) law to investigational use.


Table of Contents Get to know your MiDD..................................................................................................................................... 3

Get your MiDD ready to use ............................................................................................................................ 5

Administer medicine to your child ................................................................................................................ 7

Administer medicine to yourself .................................................................................................................... 9

How to store your MiDD ................................................................................................................................. 11

Replacing a used or empty cartridge ......................................................................................................... 11

Symbols used in labels on your MiDD and its package ........................................................................ 12


INSTRUCTIONS FOR USE

MicroDose Dispenser (MiDD)

Read these instructions to get to know your MiDD, how it works, and how to use it. The MiDD is a dispenser that mists medicine onto the surface of the eye. It has 2 parts – the cartridge that contains the study medicine, and the base that contains electronics.

• Every 30 days, you will need to remove the cartridge from the base and replace it with a new one. You will need to replace the MiDD base every year.

• The MiDD is for use only for the child for whom it is prescribed. Do not share it with others.

• If your child has an eye infection or injury to the eye, contact the study doctor as soon as possible.

Get to know your MiDD

MiDD Parts

MiDD Assembled

Front View

Fill Button

Mist Opening

Mirror with Light

Back View

Battery Light

Mist Button

Release Tab(s)

Charging

Port

USB Charging Cable

USB Wall Adapter

Base

Cartridge


Get to know your MiDD

How your MiDD works

The cartridge contains study medicine and the base provides power to the MiDD. The Battery Light tells you the MiDD is ready to use. The Fill Button is pressed to load the medicine for administration. The medicine comes out through the Mist Opening when the Mist Button is pressed. The Mist Opening is surrounded by a Light and Mirror to help align the eye for medicine delivery. The Release Tabs on each side of the cartridge are used to disconnect the cartridge from the base when the cartridge is changed every 30 days. A USB Charging Cable and Wall Adapter are provided to charge the MiDD every 30 days (when the cartridge is replaced). The Mirror Light and the Battery Light tell you the status of the MiDD.

What the Mirror and Battery Lights Mean If you see… It means…

Mirror Light

Battery Light

Mirror Light AND Battery Light SOLID BLUE Ready to dose Battery Light BLINKING GREEN Battery is charging Battery Light SOLID GREEN Battery is fully charged Battery Light BLINKING RED Battery is low Battery Light SOLID RED Charge MiDD Mirror Light AND Battery Light BLINKING BLUE - This happens if you do not use the

medicine within 1 minute after it is loaded

Warning for automatic medicine discharge

Mirror Light BLINKING BLUE AND Battery Light BLINKING RED - This happens after automatic medicine

discharge

Press Mist Button to reset MiDD


Get your MiDD ready to use Complete the steps below when you receive the Welcome Kit and each time you replace the MiDD cartridge. These steps are required only when you are assembling a new MiDD cartridge with the base. Note: If the packaging is opened or damaged, do not use the contents. Instead, contact your study site to get a new kit.

Align

Press Together

1. Assemble

a. Remove the base and cartridge from Welcome Kit

packaging.

- If you are using the Study Treatment Kit, remove 1 cartridge from the Study Treatment Kit packaging.

b. Align the cartridge and base, then press until it clicks.

Remember to keep all packaging.

This line helps align the MiDD with child’s eye when medicine is

misted

2. Set-up a. Using a permanent marker, write the date you assembled

the cartridge and base on the side of the cartridge.

You will change the cartridge every 30 days.

b. If the medicine will be given by a parent or guardian, a straight line on each side of the cartridge may help align the MiDD with your child’s eye when giving the medicine.

- If you do not see this line on your MiDD cartridge, you can draw a straight line on each side of the cartridge with the permanent marker.

- Connect to Electrical

Source

3. Charge

The MiDD must be charged prior to first use and each time you replace the cartridge. a. Slide the micro USB connector into the charging port.

b. Connect the other end of the cable to a wall outlet plug. - You can also charge the MiDD by connecting to any

USB port.

The battery light FLASHES GREEN while the battery charges. SOLID GREEN means fully charged.

Charge until the light turns SOLID GREEN.


Get your MiDD ready to use

Press Slowly Release, while counting to 3

4. Prime Cartridges must be primed using the fill button and the mist button before they’re ready for use.

a. Hold the MiDD upright.

b. Slowly press the fill button down until it stops - The mirror light turns BLUE

c. While counting to 3, slowly release the fill button.

d. Point the mist opening away from you and your child.

e. Firmly press and release the mist button

f. Repeat steps b-e four times. By the 4th time, you

should see mist coming from the mist opening.

Your new MiDD cartridge is now ready to use.

Point away from you and your child,

then press mist button

Press/release fill button, then press/release mist button.

Perform sequence 5 times


Administer medicine to your child If your child wears contact lenses, they will need to be removed before medicine administration. Before you use the MiDD each evening, you must:

• Turn on the MiDD • Do a priming spray


1. Turn MiDD ON


b. Slowly press the fill button all the way down. - The mirror light turns BLUE.

c. While counting to 3, slowly release the fill button. If the fill button feels locked or jammed: - Point the MiDD away from you and press the mist

button a few times. - Press the cartridge and base together to make

sure they are properly aligned.

2. Do a priming spray


b. Point the mist opening away from you and your child.

c. Firmly press and release the mist button.

This priming spray is required only one time each evening before administering the medicine. If you do additional sprays, you may run out of medicine before the 30-day cartridge change.

Important: Keep the MiDD upright (as shown) when loading and misting the medicine.

If the MiDD is not held upright, your child may not get their full dose of medicine.


3. Load the medicine a. Slowly press the fill button until it stops.

- The mirror light turns BLUE, meaning the medicine is ready.

b. While counting to 3, slowly release the fill button. The medicine must be administered within 1 minute. If this does not happen, the mirror light and battery light will flash BLUE and the MiDD will automatically mist the medicine. If the MiDD automatically mists the medicine: - The BLUE mirror light and RED battery light will

flash 3 times every 90 seconds. - Press and release the mist button to reset the

MiDD and try again.

Press firmly, then Release


Administer medicine to your child

Align mist opening with center of eye

4. Hold the MiDD to your child’s eye

a. Hold the MiDD with thumb over the mist button

and wrap other fingers around the front.

b. Bring MiDD to your child’s eye with the mirror light facing the eye.

- Hold about as close as the end of the nose.

- To help prevent blinking, you may use your other hand to pull the lower eyelid down or the child may pull her or him lid down.

5. Align MiDD with your child’s eye

a. Aim the mist opening toward the center of your child’s eye

b. Check alignment by confirming the marks on the side of the cartridge line up with the center of your child’s eye

- Ask your child to confirm when their eye is centered on the BLUE mirror light.

c. If your child is having trouble centering their eye on the blue light, ask her or him to look up, then look at the BLUE mirror light.

6. Press mist button a. Firmly press and release the mist button.

- Your child should feel the medicine gently wet their eye.

- If your child does not feel the medicine, prepare and administer another dose by repeating steps 3- 6.

If no mist comes out when the mist button is pressed, make sure the fill button has been pressed down completely and has returned all the way up.

7. Repeat steps 3-6 for the other eye of the child.

Alignment Mark

Eye centered on BLUE Mirror Light



Administer medicine to yourself

If you wear contact lenses, they will need to be removed before medicine administration. Before you use the MiDD each evening, you must:

• Turn on the MiDD • Do a priming spray


1. Turn MiDD ON


b. Slowly press the fill button all the way down.

- The mirror light turns BLUE.

c. While counting to 3, slowly release the fill button. If the fill button feels locked or jammed - Point the MiDD away from you and press the mist

button a few times. - Press the cartridge and base together to make

sure they are properly aligned.

2. Do a priming spray


b. Point the mist opening away from you and your child.

c. Firmly press and release the mist button.

This priming spray is required only one time each evening before administering the medicine. If you do additional sprays, you may run out of medicine before the 30-day cartridge change.

Important: Keep the MiDD upright (as shown) when loading and delivering the medicine.

If the MiDD is not held upright, you may not get your full dose of medicine.


3. Load the medicine a. Slowly press the fill button until it stops.

- The light around the mist opening turns BLUE, meaning the medicine is ready.

b. While counting to 3, slowly release the fill button. The medicine must be administered within 1 minute. If this does not happen, the mirror light and battery light will flash BLUE and the MiDD will automatically mist the medicine. If the MiDD automatically mists the medicine: - The BLUE mirror light and RED battery light will

flash 3 times every 90 seconds. - Press and release the mist button to reset the

MiDD and try again.



Administer medicine to yourself

Method A Use back of thumb to pull

lower eyelid down

Method B Use alternate hand to pull

lower eyelid down

4. Hold MiDD to your eye a. Place your thumb on the front of the MiDD and

your index finger on the mist button.

b. Hold your eye open to keep from blinking.

- Method A: Use back of thumb to pull lower eyelid down.

- Method B: Use alternate hand to pull lower eyelid down.

c. Hold MiDD with the mist opening facing your eye.

- Hold MiDD about as close as the end of your nose.

8. Align MiDD with your eye

a. Center your eye on the BLUE mirror light.

5. Press mist button a. Firmly press and release the mist button.

- You should feel the medicine gently wet your eye.

- If you do not feel the medicine in your eye, prepare and administer another dose by repeating steps 3- 5.

If no mist comes out when the mist button is pressed, make sure the fill button has been pressed down completely and has returned all the way up.

6. Repeat steps 3-5 for your other eye.

Eye centered on BLUE Mirror Light



How to store your MiDD Store at room temperature 59-86°F (15-30°C) away from direct sunlight. When not in use, the MiDD should be maintained to minimize the likelihood that the fill button will be depressed or the mist opening damaged.

- Do not heat or freeze the MiDD

- Do not get the MiDD wet or expose to fluids.

- Do not tamper with or attempt to open the MiDD cartridge or base.

The MiDD base contains a lithium ion battery1. Replacing a used or empty cartridge

The MiDD cartridge contains enough medicine for 30 days of use. Refer to the date you wrote on the side of the cartridge to determine when the cartridge should be changed.

Squeeze Release Tabs

1. Remove cartridge

a. Press and squeeze the release tabs on each side of the cartridge

b. Pull the cartridge and base apart.

c. Place used cartridge in original tray and box.

Remove new MiDD cartridge box from Study Treatment Kit

2. Replace with new cartridge

a. Remove a new cartridge box from Study Treatment Kit.

b. Follow instructions in Get your MiDD ready to use (page 4).

Manufactured By: Eyenovia New York, NY 10017

1 Damage to the base can cause fire. Do not puncture base unit or expose to excessive heat (≥ 50° C), Li-Ion batteries may pose environmental and safety hazards and should be disposed of in accordance with all applicable Federal and State Law. Check with all governing travel bodies for current requirements before air travel.


Symbols used in labels on your MiDD and its package

SYMBOL DEFINITION SYMBOL DEFINITION

CAUTION, CONSULT ACCOMPANYING DOCUMENTS

USE BY (YYYY-MM: YEAR-MONTH)

SEE INSTRUCTIONS FOR USE

STERILIZED USING ETHYLENE OXIDE

CATALOG NUMBER

NON-STERILE

BATCH CODE

DO NOT RESTERILIZE

QUANTITY

LITHIUM ION BATTERY - TO BE APPROPRIATELY RECYCLED

DATE OF MANUFACTURE (YYYY-MM : YEAR-MONTH)

KEEP DRY

MANUFACTURER

GHS LITHIUM ION DISPOSAL

DO NOT USE IF THE PACKAGING HAS BEEN OPENED OR DAMAGED

ELECTRONIC EQUIPMENT. DO NOT THROW IN TRASH.

WARNING: ELECTRICITY

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INSTRUCTIONS FOR USE Eyenovia MicroDose Dispenser ......2020/08/01 · PN-16492 Rev. A MicroPine Instructions For Use Page 3 of 12 INSTRUCTIONS FOR USE MicroDose Dispenser (MiDD)