Lasix ONYU (Furosemide): Uses, Side Effects and Dosage

Instructions for Use

Lasix^® ONYU (lay-six on-yoo) (furosemide injection) 80 mg/2.67 mL (30 mg/mL)

for Subcutaneous Use with Infusor

These Instructions for Use contains information on how to use Lasix ONYU with the Infusor.

Contact Information:

SQ Innovation, Inc.

Burlington, MA 01803, USA

Phone: 1-855-452-7496 (1-855-4LASIX6)

www.Lasix-ONYU.com

1: Important Information You Need to Know

Before Using the Lasix ONYU Infusor

• Keep the Lasix ONYU Infusor out of sight and reach of children.
• The Lasix ONYU treatment is for adult patients only as prescribed by a healthcare provider.
• For subcutaneous (under the skin) use only. The Lasix ONYU Infusor delivers the medicine just under the skin.
• Use on the stomach only. Do not use on any other area of the body.
• The Lasix ONYU Infusor is intended to be used by a single person and should not be shared .
• Do not use the Prefilled Cartridge if the solution is cloudy, yellow-brown or contains floating particles. It should be clear or light yellow. If it is not clear or light yellow, contact your healthcare provider to get a new one.
• Do not use any part of the Lasix ONYU Infusor if it has expired . If it is expired, contact your healthcare provider to get a new one.
• Do not use any part of the Lasix ONYU Infusor (Prefilled Cartridge, Disposable Unit, Reusable Unit or Charger) if it appears to be broken or damaged or does not work right. Use a new one or call SQ Innovation at 1-855-452-7496.
• Do not use a Disposable Unit if it was dropped as it may be damaged or contaminated. Use a new one.
• Do not use the Lasix ONYU Infusor if you can see the needle . Do not touch the needle or put the Lasix ONYU Infusor on your stomach, as you may get an injury. Go to Troubleshooting: You Can See the Needle for instructions on what to do.
• Do not use more than 1 Lasix ONYU Infusor at a time.
• Do not do more than 2 infusions in a 24-hour period.
• Do not use a Disposable Unit or Prefilled Cartridge more than 1 time.

Before Starting a Treatment

• Talk with your healthcare provider before using the Lasix ONYU Infusor.

  Do not start an infusion unless directed to do so by your healthcare provider.

• A healthcare provider should train you before using the Lasix ONYU Infusor by yourself.
• Read the step-by-step instructions (go to Chapter 2: How to Use the Lasix ONYU Infusor) before using the Lasix ONYU Infusor by yourself.
• You may watch the optional training video.

During a Treatment

• Start the infusion within 7 hours of preparing the Lasix ONYU Infusor.
• The infusion will last about 5 hours. During this time, you should limit your activities so that your bending movements are limited. Wearing the Lasix ONYU Infusor while riding in a car or airplane is not recommended. Be sure you have access to a bathroom after starting the infusion. You should urinate (pee) a lot and will need to make frequent bathroom visits.
• Frequent urination is to be expected during use of the Lasix ONYU Infusor. Be sure you have access to a bathroom for up to 8 hours after starting the infusion.
• Call your healthcare provider if you did not urinate a lot (at least 2 times during the 5-hour infusion).
• Do not apply lotions, oils, or ointments to the stomach area where you will apply the Lasix ONYU Infusor.
• Do not get the Lasix ONYU Infusor wet. Doing so may damage the Lasix ONYU Infusor. Do not shower, bathe, or swim while wearing the Lasix ONYU Infusor.
• Do not remove the Lasix ONYU Infusor from the stomach until the infusion is done. Removing the Lasix ONYU Infusor before stopping it will expose the needle, and may injure you or others. Go to How to Stop the Lasix ONYU Infusor Early if you need to stop the infusion early.
• Do not use the Lasix ONYU Infusor in or around a Magnetic Resonance Imaging (MRI) machine.
• Do not use the Lasix ONYU Infusor within 12 inches of mobile phones, tablets, computers, or wireless accessories (for example: TV remote control, Bluetooth computer keyboard or mouse) during the 5-hour infusion. It may cause the Lasix ONYU Infusor to break.

2: How to Use the Lasix ONYU Infusor

Inside the Box

Contents of the Lasix ONYU Kit

Note: The Single-Dose Prefilled Cartridge is referred to as Prefilled Cartridge throughout this Instructions for Use.

Contents of the Reusable Unit and Charger Box

Contents of the Lasix ONYU Starter Kit

Supplies not included:

• Cotton ball and small adhesive bandage (if needed) for Step 21 in End the Infusion .

• You will also need a sharps disposal container for Step 25 in Throw Away (Disposal), Cleaning, and Storage . You may obtain a free sharps disposal container from SQ Innovation. Visit www.Lasix-ONYU.com/sharps/ or call 1-855-452-7496 to have a container mailed

  to you at no charge.

Get to Know the Lasix ONYU Infusor Parts

Get Ready for the Infusion

Do not start an infusion unless directed to do so by your healthcare provider.

Step 1

Gather the white Reusable Unit, Charger, and 1 Lasix ONYU Kit.

Only use the Charger that has been provided.

Do not use if the Disposable Unit was dropped or if any parts appear to be broken or damaged . Use a new one.

Step 2

Charge the Reusable Unit. Plug the Charger into the back of the white Reusable Unit and a power outlet. Check the Battery Light:

• When the Battery Light turns solid blue, unplug the charger from the Reusable Unit. The Reusable Unit is ready to use.
• If the Battery Light is flashing blue, wait for charging to finish.

• If any lights are red, unplug the Charger and plug it back in. If the lights are still red, go to Troubleshooting: Lights and Tones Table for instructions.

  Always charge the Reusable Unit before each infusion.

Prepare the Medicine

Step 3

Wash your hands with soap and water.

Step 4

Check the expiration date on the Lasix ONYU Kit.

Do not use if the expiration date has passed .

Step 5

Gather all supplies needed. On a clean, flat, well-lit work surface, open 1 Lasix ONYU Kit and remove the contents.

Do not open the contents until you are ready to start the infusion.

Do not use the Disposable Unit if the sealed packaging appears to be damaged. Use a new one.

Do not use the Disposable Unit if it was dropped or if any parts appear to be broken. Use a new one.

Step 6

Remove Prefilled Cartridge, Disposable Unit, and 2 alcohol pads from packaging:

• Remove the Prefilled Cartridge from its box and sealed tray.
• Remove the Disposable Unit from its sealed package.

Do not remove the paper liner from the back of the Disposable Unit.

Step 7

Check the Prefilled Cartridge appearance.

Do not use the Prefilled Cartridge if the medicine is cloudy , appears yellow-brown , or you see floating particles.

Step 8

Wipe the silver top of the Prefilled Cartridge with an alcohol pad.

Step 9

Push the Prefilled Cartridge into the green Disposable Unit with the silver top inserted first.

The Prefilled Cartridge is fully inserted when the bottom of the Prefilled Cartridge is at the tip

of the arrow on the Disposable Unit.

Prepare the Lasix ONYU Infusor

Step 10

Check the following:

• The Reusable Unit Battery Light is solid blue, and

• The Charger is disconnected from the Reusable Unit.

  Slide together the white Reusable Unit and green Disposable Unit together until the Status Light on the Reusable Unit turns on.

Step 11

Check the Status Light.

• If the Status Light is blue and flashing fast, and you hear the OK Tone (1 long beep), continue to Step 12. The Lasix ONYU Infusor is ready to start your infusion.
• The Lasix ONYU Infusor will remain ready to start infusion for 7 hours.
• If the Status Light is flashing red and you hear the Alarm Tone (2 short beeps), do not use the Lasix ONYU Infusor. Go to Troubleshooting: The Status Light is Flashing Red for instructions.
• If the Battery Light is solid red, do not use the Lasix ONYU Infusor. Go to Troubleshooting: Checking the Reusable Unit Battery for instructions.

Prepare the Application Site

Step 12

Choose a site on the stomach, above the beltline, to the left or right of the belly button.

Trim excessive hair at the site. This will help the Lasix ONYU Infusor stick to the skin.

Alternate (rotate) sites between left and right sides of the stomach with each infusion.

Do not choose a site where:

• the skin is irritated, broken, tender, red, bruised, or hard,
• the skin is wet or sweaty,
• there are folds in the skin when standing up straight, or
• belts, waistbands, or tight clothing may rub against or move the Lasix ONYU Infusor.

Step 13

Wipe the site with an alcohol pad.

Let dry for at least 10 seconds.

Attach the Lasix ONYU Infusor

Step 14

Hold the blue tab with one hand and use the other hand to peel off the paper liner from the adhesive on the back of the Lasix ONYU Infusor.

Leave the sticky adhesive on the Lasix ONYU Infusor. Only remove the paper liner.

Do not touch the sticky adhesive with your fingers or let it touch any surfaces before sticking the Lasix ONYU Infusor to your stomach.

Step 15

While standing up straight, press the Lasix ONYU Infusor onto the site on your stomach you wiped with the alcohol pad.

Make sure the Status Light and the Start/Stop Button are facing up in a horizontal position as shown, so you can see them when the Lasix ONYU Infusor is on your stomach.

Step 16

Rub the edges of the adhesive with a finger to get the Lasix ONYU Infusor to stick well.

Start the Infusion

Start your infusion within 7 hours of connecting the Reusable Unit and Disposable Unit. If more than 7 hours pass without starting your infusion, the Lasix ONYU Infusor will time out and the infusion cannot be delivered (go to Troubleshooting: The Status Light is Flashing Red).

Step 17

Press and hold the Start/Stop Button until you hear the motor and see the blue Status Light change to flashing slow.

The needle will automatically insert into your skin after the Start/Stop Button is pressed. You may feel a slight pinch.

You will hear the motor start and stop often during your infusion. The motor runs for a few seconds at a time then pauses for several minutes.

Step 18

Check the Status Light.

• If the Status Light is blue and flashing slow, and you hear the OK Tone (1 long beep), the infusion has started. You will hear the motor running.
• If the Status Light is flashing red, and you hear the Alarm Tone (2 short beeps), the infusion did not start. Go to Troubleshooting: The Status Light is Flashing Red for instructions.
• If the Status Light is blue and flashing fast, and you hear the OK Tone (1 long beep), the infusion did not start. Repeat Step 17 .
• For additional assistance go to Troubleshooting: Lights and Tones Table for instructions or call 1-855-452-7496.

During the Infusion

Step 19

Wait 5 hours for the Lasix ONYU Infusor to deliver the full infusion.

You will see the blue Status Light flashing slow and sometimes hear the motor running.

Check the Lasix ONYU Infusor every now and then to make sure it is working properly.

Do not remove the Lasix ONYU Infusor from your stomach until the infusion is done. The infusion is complete when the Status Light is solid blue and you hear the OK Tone (1 long beep). Go to Troubleshooting: How to Stop the Infusor Early if you need to stop the infusion early.

End the Infusion

Step 20

After 5 hours, check the Status Light.

• If the Status Light is solid blue, and you hear the OK Tone (1 long beep), the infusion is done .
• If the Status Light is flashing red, and you hear the Alarm Tone (2 short beeps), an error happened. Go to Troubleshooting: The Status Light is Flashing Red.
• If the Status Light is blue and flashing slow, and you hear the OK Tone (1 long beep), the infusion is not done yet. Continue to wait.

The needle automatically pulls in (retracts) when the infusion is done. You may feel a slight pinch.

Step 21

When the infusion is done, remove the Lasix ONYU Infusor from your stomach. Peel the Lasix ONYU Infusor off the skin by holding down the skin and pulling the blue tab away from the stomach.

You might have some discomfort after you remove the Lasix ONYU Infusor. This discomfort should quickly go away, but some redness of the skin may remain. If there is any bleeding, pat with a small cotton ball or apply a small adhesive bandage over the site.

Confirm the Infusion Worked

Step 22

Look in the window on the back of the Infusor to check whether all the medicine was delivered.

• If the middle of the window is all gray (whole gray stopper is visible with very little or no liquid), all of the medicine was delivered.

  If you see anything else (like a lot of liquid, a large bubble in the liquid, no gray stopper, or only part of the gray stopper), some of the medicine was not delivered. Call your healthcare provider right away.

Step 23

Confirm the medicine worked.

• If you urinate a lot (at least 2 times during the 5-hour infusion), the medicine worked.
• If you urinate less than 2 times (during the 5-hour infusion), the medicine may not have worked. Call your healthcare provider right away.

Throw Away (Disposal), Cleaning, and Storage

Step 24

Pull apart the green Disposable Unit and white Reusable Unit.

The Reusable Unit automatically turns off when the two parts are separated.

Step 25

Do not save and re-use the green Disposable Unit or Prefilled Cartridge. They are for one-time use only.

Throw away the green Disposable Unit into an FDA-cleared sharps disposal container.

You may obtain a free sharps disposal container from SQ Innovation. Visit www.Lasix-ONYU.com/sharps/ or call 1-855-452-7496 to have a container mailed to you at no charge.

Alternatively, if you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

• made of heavy-duty plastic,
• can be closed with a tight fitting, puncture-resistant lid, without sharps being able to come out,
• upright and stable during use,
• leak-resistant, and
• properly labeled to warn of hazardous waste inside the container.

When your Sharps container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you throw away used needles and syringes. For more information about safe sharps disposal and for specific information about sharps disposal in the state that you live in, go to the FDAs website at:

https://www.fda.gov/medical-devices/safely-using-sharps-needles-and-syringes-home-work-and-travel/best-way-get-rid-used-needles-and-other-sharps

Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.

Do not recycle the green Disposable Unit and used sharps disposal container or throw them away into household trash.

Important: Always keep the sharps disposal container out of the reach of children.

Scan the code below with your phone for a sharps disposal location near you or call Safe Needle Disposal at 1-800-643-1643.

Step 26

Wipe the white Reusable Unit with a clean, water-damp cloth to remove visible dirt right after use. Let dry completely before storing.

If needed, a mild detergent, like dish soap, may be added to the damp cleaning cloth.

Do not use harsh cleaners that contain bleach, alcohol, ammonia, or other solvents. These cleaners may damage the Reusable Unit.

Do not submerge the Reusable Unit in liquids or spray liquids directly on the surface. It contains parts that should not get wet.

Step 27

Store the Reusable Unit, Charger, and any remaining Lasix ONYU Kits for next use.

• Keep at room temperature between 68°F and 77°F (20°C and 25°C).
• Do not refrigerate or freeze.
• Keep in a dark place to protect from light.
• Keep dry.
• Keep extra Prefilled Cartridges and Disposable Units in their original packaging until it is time to use them.

3: Troubleshooting

Customer Service Contact Information

Contact Information:

SQ Innovation, Inc.

Burlington, MA 01803, USA

Phone: 1-855-452-7496 (1-855-4LASIX6)

www.Lasix-ONYU.com

Lights and Tones Table

Checking the Reusable Unit Battery

If the Battery Light is charged, the white Reusable Unit is able to deliver a full infusion. If the Battery Light is low, the Reusable Unit cannot deliver a full infusion and it needs to be charged.

Always charge the Reusable Unit before you use a new Disposable Unit (before each infusion).

Charging may take up to 20 minutes.

A. Battery Light is flashing blue

The Reusable Unit battery is being charged . Wait until the Battery Light turns solid blue before using the Lasix ONYU Infusor.

B. Battery Light is solid blue

The Reusable Unit battery is done charging and ready to use.

C. Battery Light is solid red before preparing the Lasix ONYU Infusor for use

The Reusable Unit battery is low and cannot deliver a full infusion.

Charge the Reusable Unit:

1. 1. Plug the Charger into the back of the Reusable Unit.
2. 2. Plug the other end of the Charger into a power outlet.
3. 3. Wait until the Battery Light turns solid blue.

D. Battery Light is solid red when the Disposable Unit and Reusable Unit are connected

The Reusable Unit battery is low and the Lasix ONYU Infusor will not start.

1. 1. Pull apart the white Reusable Unit and green Disposable Unit.
2. 2. Put the Disposable Unit to the side while you charge the Reusable Unit (do not remove the Prefilled Cartridge from the Disposable Unit).
3. 3.

   Charge the Reusable Unit:

   1. 1. Plug the Charger into the back of the Reusable Unit.
   2. 2. Plug the other end of the Charger into a power outlet.
   3. 3. Wait until the Battery Light turns solid blue.
   4. 4. Follow instructions beginning with Step 10 in Prepare the Lasix ONYU Infusor to connect the Reusable Unit to the Disposable Unit.

The Reusable Unit Has Expired

When the Reusable Unit expires, the Lasix ONYU Infusor can no longer be used. The Reusable Unit needs to be replaced.

The Reusable Unit is expired if it does not light up at all after charging or the Status Light and the Battery Light are both solid red when the Reusable Unit is plugged in or when the Reusable Unit and Disposable Unit are pulled apart.

Call 1-855-452-7496 for a replacement Reusable Unit, which will be shipped overnight when possible. Also call your healthcare provider.

The Reusable Unit should not be thrown away (disposed of) with household waste and should not be recycled in your local recycling program. Throw away the Reusable Unit according to local regulations for electronic devices with lithium batteries.

Alternatively, the Reusable Unit may be returned to SQ Innovation, free of charge, for proper and safe recycling. Go to Chapter 4 for more information.

The Status Light is Flashing Red

When an error happens inside the Lasix ONYU Infusor or the white Reusable Unit and green Disposable Unit have been connected for 7 hours without starting infusion , the Status Light will flash red and you will hear a repeating Alarm Tone (2 short beeps).

This can happen in the following 2 situations:

• Before the white Reusable Unit and green Disposable Unit are connected, see Section A below for what to do.
• After the white Reusable Unit and green Disposable Unit are connected, see Section B below for what to do.

A. If the Status Light flashes red before the white Reusable Unit is connected to the green Disposable Unit, a device error happened. Follow the instructions below:

1. 1. Unplug the Charger (if it is connected).
2. 2. Press and hold the Start/Stop Button until the flashing red light turns off (1 second).
3. 3.

   Plug the charger into the Reusable Unit and a power outlet. Check the Lights:

   • If the Battery Light is solid or flashing blue, the Reusable Unit is ready to use. Continue with Step 2 in Get Ready for the Infusion.

   • If the Status Light is still flashing red , the Reusable Unit cannot be used. Call 1-855-452-7496 for a replacement Reusable Unit, which will be shipped overnight when possible. Also call your healthcare provider.

     

B. If the Status Light flashes red after connecting the white Reusable Unit and green Disposable Unit, a device error happened or the Lasix ONYU Infusor timed out (because it was connected for 7 hours without starting the infusion). The Lasix ONYU Infusor cannot be used. Follow the steps below:

1. 1. If the Lasix ONYU Infusor is on the body, remove it from the stomach.
2. 2. If you can see the needle, do not touch the needle because you could get an injury.
3. 3. Pull apart the Reusable Unit and Disposable Unit.
4. 4.

   Throw away the Disposable Unit with the Prefilled Cartridge into an FDA-cleared sharps disposal container (see Step 25 in Throw Away (Disposal), Cleaning, and Storage). You should not throw away the Disposable Unit in the household trash.

   • Do not save and re-use the Disposable Unit or Prefilled Cartridge as the medicine may be contaminated. They are for one-time use only.
5. 5.

   Determine the next steps:

   1. 1. If the error happened before the infusion was started , get a new Lasix ONYU Kit and start over at Step 1 in Get Ready for the Infusion.
   2. 2. If the error happened after the infusion was started, call your healthcare provider to see what to do because some of the medicine was not delivered.

You Can See the Needle

You may see the needle in one of these situations:

• You press the Start/Stop Button before the Lasix ONYU Infusor is placed on the stomach, see Section A below for what to do.
• You remove the Infusor before infusion is done or the Lasix ONYU Infusor falls off during the 5-hour infusion, see Section B below for what to do.
• The needle did not retract automatically after infusion, see Section C below for what to do.

Do not touch the needle because you could get an injury.

A. If you see the needle before the Lasix ONYU Infusor is placed on the stomach, you should start over with a new Lasix ONYU Kit. Follow the steps below:

1. 1. Press and hold the Start/Stop Button (4 seconds) until the Status Light flashes red and you hear the Alarm Tone (2 short beeps).
2. 2. Pull apart the white Reusable Unit and green Disposable Unit.
3. 3.

   Throw away the Disposable Unit with Prefilled Cartridge into an FDA-cleared sharps disposal container. You should not throw away the Disposable Unit in the household trash.

   • Do not save and re-use the Disposable Unit or Prefilled Cartridge as the medicine may be contaminated. They are for one-time use only.
4. 4. Return to Step 1 in Get Ready for the Infusion to start over with a new Lasix ONYU Kit. Be careful not to press the Start/Stop Button until after the Lasix ONYU Infusor is on the stomach.

B. If you see the needle because the Lasix ONYU Infusor fell off or it was removed before infusion was done, follow the steps below:

You should not stick the Infusor back on the stomach because it may fall off again.

1. 1. Press and hold the Start/Stop Button (4 seconds) until the Status Light flashes red and you hear the Alarm Tone (2 short beeps).
2. 2. Pull apart the white Reusable Unit and green Disposable Unit.
3. 3.

   Throw away the Disposable Unit with the Prefilled Cartridge into an FDA-cleared sharps disposal container. You should not throw away the Disposable Unit in the household trash.

   • Do not save and re-use the Disposable Unit or Prefilled Cartridge as the medicine may be contaminated. They are for one-time use only.
4. 4. Call your healthcare provider to see what to do because some of the medicine was not delivered.

C. If you see the needle after the 5-hour infusion is done, the needle did not retract automatically. Follow the steps below:

1. 1. Carefully pull apart the white Reusable Unit and green Disposable Unit.
2. 2.

   Throw away the Disposable Unit with the Prefilled Cartridge into an FDA-cleared sharps disposal container. You should not throw away the Disposable Unit in the household trash.

   • Do not save and re-use the Disposable Unit or Prefilled Cartridge as the medicine may be contaminated. They are for one-time use only.
3. 3. Continue with Step 26 and Step 27 in Throw Away (Disposal), Cleaning, and Storage to clean and store the Reusable Unit.

How to Stop the Lasix ONYU Infusor Early

Follow these steps below if you need to stop the Lasix ONYU Infusor before the 5-hour infusion is finished. Do not remove the Lasix ONYU Infusor from the stomach before stopping it. Removing the Lasix ONYU Infusor from the body before stopping it will expose the needle, and you could get an injury if you touch it.

1. 1. Press and hold the Start/Stop Button (4 seconds) until you hear the Alarm Tone (2 short beeps) and the Status Light is flashing red.
2. 2.

   Confirm infusion was stopped. Check the Status Light:

   • If the Status Light is flashing red and you hear the Alarm Tone (2 short beeps), infusion has stopped. The needle will retract shortly after you press the Start/Stop Button.

   • If the Status Light is blue and flashing slow, the infusion did not stop. Repeat Step 1 in How to Stop the Lasix ONYU Infusor Early above.

     

3. 3.

   The infusion cannot be restarted. You must remove the Lasix ONYU Infusor and contact your healthcare provider. Follow the steps below:

   1. 1. Remove the Lasix ONYU Infusor from your stomach.
   2. 2. Pull apart the white Reusable Unit and green Disposable Unit.
   3. 3. Throw away the Disposable Unit withthe Prefilled Cartridge in an FDA-cleared sharps disposal container. You should not throw away the Disposable Unit in the household trash.
   • Do not save and re-use the Disposable Unit or Prefilled Cartridge as the medicine may be contaminated. They are for one-time use only.
   • Call your healthcare provider because you did not get all of the medicine.

You Did Not Urinate (Pee) Much During Infusion

The Lasix ONYU Infusor delivers a diuretic medicine which should make you urinate a lot. If you do not urinate a lot (at least 2 times during the 5-hour infusion), there are two reasons this could have happened:

• The diuretic medicine, Lasix ONYU, was not effective for you, or
• The Lasix ONYU Infusor did not work properly.

In either case, it is important that you call your healthcare provider. Follow the steps below to determine whether the Lasix ONYU Infusor worked and if all the medicine was delivered:

1. 1. Remove the Lasix ONYU Infusor from your stomach.
2. 2.

   Look at the window on the back of the Lasix ONYU Infusor:

   • If the middle of the window is all gray (whole gray stopper is visible with very little or no liquid), all the medicine was delivered. The Lasix ONYU Infusor worked.
   • If you see anything else (like a lot of liquid, a large bubble in the liquid, no gray stopper, or only part of the gray stopper), some of the medicine was not delivered. You did not get a full infusion.
3. 3. Check your stomach: If you see or feel a lot of liquid on your stomach, you may not have received a full infusion due to the medicine leaking.

The Reusable Unit Does Not Light Up

This can happen in the following situations:

• The Reusable Unit has not been used for a long time or the Reusable Unit is expired, see Section A below for what to do.
• The Reusable Unit and Disposable Unit have been connected for more than 7 hours and infusion has not been started, see Section B below for what to do.

A. If the white Reusable Unit does not light up, try charging it, even if it has recently been charged. The Battery Light on the Reusable Unit must always be solid blue before connecting it to the Disposable Unit.

Follow the steps below:

1. 1. Plug the Charger into the back of the Reusable Unit and plug the other end of the Charger into a power outlet.
2. 2. Wait 20 minutes.
3. 3. Disconnect the Charger from the Reusable Unit and power outlet.
4. 4.

   Check the Battery Light:

   • If the Battery Light is solid blue, the Reusable Unit is ready to use.
   • If the Battery Light did not light up after 20 minutes of charging, the Reusable Unit expired. Call 1-855-452-7496 for a replacement Reusable Unit, which will be shipped overnight when possible. Also call your healthcare provider. Go to Troubleshooting: The Reusable Unit Has Expired for more information.
   • If you see other lights, go to Troubleshooting: Lights and Tones Table.

B. If the Reusable Unit and Disposable Unit have been connected for more than 7 hours and infusion has not been started, the Lasix ONYU Infusor will automatically time out. The Lasix ONYU Infusor cannot be restarted.

Follow the steps below:

1. 1. If the Lasix ONYU Infusor is on the body, remove the Lasix ONYU Infusor from your stomach.
2. 2.

   If you can see the needle, do not touch the needle because you could get an injury.

   

3. 3. Pull apart the Reusable Unit and Disposable Unit.
4. 4.

   Throw away the Disposable Unit with the Prefilled Cartridge in an FDA-cleared sharps disposal container. You should not throw away the Disposable Unit in the household trash.

   • Do not save and re-use the Disposable Unit or Prefilled Cartridge as the medicine may be contaminated. They are for one-time use only.
5. 5. Get a new Lasix ONYU Kit and start over at Step 1 in Get Ready for the Infusion.

The Lasix ONYU Infusor Will Not Start the Infusion

You press the Start/Stop Button and the infusion does not start.

This can happen in the following situations:

• The Reusable Unit and Disposable Unit are not properly connected, see Section A below for what to do.
• The Reusable Unit is powered off and both the Battery Light and Status Light are off, go to Troubleshooting: The Reusable Unit Does Not Light Up for what to do.
• A device error has happened and the Status Light is flashing red, go to Troubleshooting: The Status Light is Flashing Red for what to do.

A. If the infusion does not start, follow the steps below:

1. 1. Firmly push the Reusable Unit and Disposable Unit together. There should be no gap or space between the parts when they are properly connected.
2. 2.

   Check the Status Light:

   • If the Status Light is blue and flashing fast and you hear the OK Tone (1 long beep), the Lasix ONYU Infusor is properly connected. The Lasix ONYU Infusor is ready to deliver infusion.

     If the Lasix ONYU Infusor is not on the body, go to Step 12 in Prepare the Application site.

     If the Lasix ONYU Infusor is on the body, go to Step 17 in Start the infusion.

   • If the Status Light is flashing red and you hear the Alarm Tone (2 short beeps), there is a problem with the Infusor. Go to Troubleshooting: The Status Light is Flashing Red to see what to do.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Issued: 10/2025

SP110004US

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