- Patient Information
- Before Taking Tyvaso, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
- Especially Tell Your Healthcare Provider If You Take:
- How Should I Take Tyvaso?
- What Are The Ingredients In Tyvaso?active Ingredient:
- Inactive Ingredients:
- Follow These Important Instructions To Ensure Proper Use:
- Follow These Important Instructions Before Setting Up Your Treatment:
- Before Using The Tyvaso Inhalation System, You Should:
- To Install A New Filter Membrane:
- Technique:
- Inhalation:
- Accessories:
- Control Light For Inhalation:
- Baffle Plate:
- Display Screen:
- Distilled Water:
- Dome Assembly:
- Filter Membrane:
- Filter Shells:
- Inhalation Piece:
- Inhalation Device:
- Medicine Cup:
- Mouthpiece:
- On/off Button:
- Prompts:
- Status Light:
- Start/stop Treatment Button:
- Specialty Pharmacy Provider:
- Treatment Session:
- For All Inquiries Relating To Service Or Warranty For Your Tyvaso Inhalation System, Contact Your Specialty Pharmacy Provider. You Should Have The Following Information Available:
- Distributed By:
- Delivering Treatments:
- Handling The Device:
- Your Environment:
- Important:
- What Is Covered In This Section:
- Caution:
- The Battery Icon At The Bottom Of The Screen Indicates Battery Status:
- What You Will Need:
- For Further Support, You Can:
- Interference May Occur In The Vicinity Of Equipment Marked With The Following Symbol:
- Black Ring:
- Inhalation Indicator Lights:
- On/off, Start/pause (blue) Button:
- Power Status Light:
- Power Port:
- Run / Program Switch:
- Sensors:
- Volume / Breaths Toggle Button:
- Water Chamber:
- Circumstances That May Void Your Warranty Include:
- You Should Have The Following Information Available:
- United Therapeutics:
Patient Information ⮝
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Train patients in the administration process for Tyvaso, including dosing, Tyvaso Inhalation System set up, operation, cleaning, and maintenance, according to the instructions for use[
Tyvaso is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of your lungs.
Tyvaso can improve the ability to exercise. Your ability to exercise decreases 4 hours after treatment with Tyvaso.
It is not known if Tyvaso is safe and effective in children under 18 years of age.
Before Taking Tyvaso, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You: ⮝
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tyvaso and other medicines may affect each other.
- have lung disease, such as asthma or chronic obstructive pulmonary disease (COPD)
- have a lung infection
- have liver problems or kidney problems
- have low blood pressure
- have bleeding problems
- are pregnant or plan to become pregnant. It is not known if Tyvaso will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if Tyvaso passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Tyvaso.
Especially Tell Your Healthcare Provider If You Take: ⮝
Know the medicines you take. Keep a list of them and show it to your healthcare provider and specialty pharmacist when you get a new medicine.
- medicines used to treat high blood pressure or heart disease
- medicines that decrease blood clotting (anticoagulants)
- water pills (diuretics)
- gemfibrozil (Lopid)
- rifampin (Rimactane, Rifadin, Rifamate, Rifater)
How Should I Take Tyvaso? ⮝
Keep Tyvaso and all medicines out of the reach of children.
- Store at 25 C (77 F), with excursions permitted to 15 C to 30 C (59 F to 86 F) [see USP Controlled Room Temperature].
- Store Tyvaso ampules in the unopened foil pouch and out of the light until you are ready to use them.
- If unopened and stored in the foil pouch, Tyvaso ampules can be used until the expiration date printed on the pouch. Do not use Tyvaso ampules past the expiration date printed on the pouch.
- Tyvaso ampules should be used within 7 days after opening the foil pouch.
- Tyvaso can be kept in the Tyvaso Inhalation System medicine cup for no more than 1 day. Throw away any remaining Tyvaso that is left in the medicine cup at the end of the day.
General information about the safe and effective use of Tyvaso.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Tyvaso for a condition for which it was not prescribed. Do not give Tyvaso to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or specialty pharmacist for information about Tyvaso that is written for health professionals.What Are The Ingredients In Tyvaso?active Ingredient: ⮝
treprostinilInactive Ingredients: ⮝
sodium chloride, sodium citrate, sodium hydroxide, hydrochloric acid, and water for injection
Manufactured by: United Therapeutics Corp., Research Triangle Park, NC 27709 USA
Tyvaso is a registered trademark of United Therapeutics Corporation.
Copyright2017, United Therapeutics Corp. All rights reserved.
For more information, go to www.tyvaso.com or call 1-877-864-8437.TYVASO
INHALATION SYSTEM
Instructions for UseTYVASO
(treprostinil)
INHALATION
SOLUTIONTable of Contents
General Instructions 2 Introduction 3 Preparing for Treatment With TYVASO 3 Preparing the Use Environment for Treatment 3 Markings, Indicators, and Symbols 4 Gathering Supplies 6 Setting Up Your TYVASO Inhalation System 8 Filling the Inhalation Device Chamber and Medicine Cup 8 Assembling the Inhalation Device 10 Turning On the Inhalation Device 13 Setting the Number of Breaths in a Treatment Session 14 Inhaling Your Medicine (TYVASO) 16 Storing the TYVASO Inhalation System Between Treatment Sessions 20 Cleaning and Maintenance of the TYVASO Inhalation System 24 End of Day Cleaning of the Accessories 24 Weekly Cleaning 27 Monthly Refill Kit 27 Device Replacement 27 Charging Your TYVASO Inhalation System 28 Rechargeable Battery 28 Troubleshooting the TYVASO Inhalation System 30 Specifications 36 Glossary 38 Warranty Information 40 General Instructions
The TYVASO Inhalation System should be handled with care.
Follow These Important Instructions To Ensure Proper Use: ⮝
- Always unplug the device after each use.
- Do not immerse the device in water or other liquids.
- Do not place the device in a microwave or regular oven.
- Do not place the device or use the device in the presence of strong electric or magnetic fields (eg, microwave oven, magnetic imaging equipment).
- Do not leave the device alone with a small child.
- Do not use the device near flammable liquids and materials or heated surfaces.
- Read the instructions carefully and completely to prevent damage to your TYVASO Inhalation System and help you get the best results.
- This device should only be used on the order of your doctor or licensed healthcare practitioner.
- Ensure the breath counter is correctly programmed prior to beginning a treatment (see page 14).
- Do not peel or remove the labels from device.
- Do not drop the device.
Introduction
Your doctor has prescribed TYVASO(treprostinil) Inhalation Solution. Please see the accompanying Patient Package Insert for important safety information on TYVASO.
TYVASO is breathed in (inhaled) using the TYVASO Inhalation System, which consists of the inhalation device and its accessories.
These Instructions for Use (IFU) for the TYVASO Inhalation System provide important safety information. It is important that you read these instructions and the TYVASO Patient Package Insert (PPI) before setting up and using the TYVASO Inhalation System. If you have any questions, talk to your doctor or specialty pharmacy provider.
Before beginning treatment with TYVASO, you will receive either a Patient Starter Kit containing a 28-day supply of TYVASO or an Institutional Starter Kit containing a 4-day supply of medication. Both kits include two (2) complete inhalation devices (all accessories and supplies included). When you refill your prescription for TYVASO each month, you will receive a Refill Kit that contains a 28-day supply of TYVASO and new accessories. You will receive a replacement device every two (2) years.
Preparing for Treatment With TYVASO
Preparing the Use Environment for Treatment
Follow These Important Instructions Before Setting Up Your Treatment: ⮝
- Use the device in a quiet, distraction-free area.
- Try to use the device at times when your treatment will not be interrupted. If you encounter any distractions during treatment, you can pause your treatment (see page 19).
- Use the device in a comfortable space where you can stand or sit in an upright position that allows you to take deep breaths.
- Use the device in an area that provides enough space for the TYVASO Inhalation System and its accessories.
- Gather all necessary supplies before starting to prepare for treatment (see pages 6 and 7).
- The TYVASO Inhalation System is recommended for use indoors. Be sure to use and store the inhalation device in environments that match the specified temperature and humidity ranges (seeSpecificationson page 36).
Markings, Indicators, and Symbols
Device markings
The TYVASO Inhalation System complies with the requirements of Protection Class II. Class II equipment provides additional precautions, over and above basic insulation, to provide protection against electric shock. Please read the accompanying instructions and labels for important information regarding the TYVASO Inhalation System. The TYVASO Inhalation System has a Type B Applied part. Type B Applied parts comply with specific requirements to provide protection against shock and are not suitable for direct cardiac applications. The TYVASO Inhalation System should only be used on the order of your doctor or licensed healthcare provider. The TYVASO Inhalation System requires a 12V DC power supply. Gathering Supplies
Gather the following supplies before starting treatment. Use only the parts and accessories that are provided with your starter kit or in the monthly refill kit. Note: supplies are not shown to scale.
1. Inhalation device 2. Water Level Cup with 45 mL of distilled water 3. Pack of TYVASO ampules
Use only distilled water to fill your inhalation device once per day. Use one (1) ampule per day. 4. One of the provided power sources
Note: Supplies are not shown to scale.
- *
- These accessories are replaced every month. Replacement accessories are included in the Monthly Refill Kit.
5. Accessories Medicine cups* Dome assembly with baffle plate inside* Inhalation piece* Mouthpiece* Two (2) Filter shells* Filter membranes (use two (2) per day)* Plugs* Treatment Tracker* Carrying case Distilled water carrier (optional) Setting Up Your TYVASO Inhalation System
Filling the Inhalation Device Chamber and Medicine Cup
Before Using The Tyvaso Inhalation System, You Should: ⮝
- Wash your hands
- Make sure the device isNOTconnected to a power source
- Make sure the device is resting on a stable, flat surface during assembly
ONLY USE DISTILLED WATERin the device. Distilled water is highly purified water that can be purchased at most grocery stores and pharmacies. It is necessary for the device to function properly. If you use another type of water (such as bottled or tap water), the device may not function properly.
1
Fill the white chamber inside the device with approximately 45 mL of distilled water (about 1.5 ounces), using the water level cup provided. Fill the cup until water level is between the two arrow markings.There is a silver sensor on the inside wall of the chamber. The water level should be above the silver sensor and below the blue ring in the device chamber. DO NOT OVERFILL the chamber, or the medicine cup will not fit correctly. Check the water level after filling the chamber.
2
Obtain one (1) medicine cup and inspect it for any damage, holes, cracks, or dents. Do not use the medicine cup if it is damaged.Insert the empty medicine cup into the chamber of the device, making sure that the cup's bottom tip is in the distilled water. The cup will sit on the blue ring.
3
Carefully cut open the top of the foil pouch, making sure not to cut the ampules. Each pouch contains four (4) ampules.Remove one (1) ampule of TYVASO. Keep unused ampules in the foil pouch because the TYVASO medicine is sensitive to light.
One (1) ampule contains enough medicine for one (1) day of treatment no matter how many breaths your doctor has prescribed.
4
Gently hold the ampule in the upright (topup) position and twist off its top.5
Point the ampule straight down toward the medicine cup's center to avoid spills.Gently squeeze the medicine out of the ampule into the medicine cup. Squeeze until it is empty. Check to see that all of the medicine is in the medicine cup.
Assembling the Inhalation Device
The TYVASO Inhalation System is designed so the parts only fit together properly one way.
When the device is assembled correctly, the parts should fit together easily.
Do not force the parts together.
1
Visually check to make sure the blue plastic baffle plate and black ring are correctly placed in the dome assembly. They should appear as they do in the images below.In the unlikely event that the baffle plate is loose or disconnected, use a new dome assembly. If you need to order a new dome assembly, contact your specialty pharmacy provider.
2
Align the raised circle on the side of the dome assembly with the circle on the side of the device. Push down and screw the dome assembly onto the device clockwise (right) until you hear a click, indicating the dome assembly is fully connected to the medicine cup. When the dome assembly is properly aligned, the filter shell port will point to the back of the device.3
Insert the inhalation piece into the upper opening of the dome assembly and rotate toward the front of the device. Gently push down the inhalation piece to make sure it is securely inserted in the dome assembly.4
Insert the mouthpiece into the inhalation piece.5
Each day you will need to use a new filter membrane in each filter shell.
To Install A New Filter Membrane: ⮝
- Open the filter shell by unscrewing the two (2) halves.
- Place a new filter membrane in one (1) of the filter shell halves.
- Close the filter shell by screwing the two (2) halves together until you can twist no further.
Note: New filter shells come with fresh filter membranes already installed.
6
Insert one (1) of the filter shells into the filter shell port on the side of the dome assembly and insert the other filter shell into the port on the bottom of the inhalation piece. The two (2) filter shells are identical and can be used in either opening.Make sure to insert the filter shells straight into their ports, rather than at an angle. If necessary, rotate the inhalation piece so you can insert the filter shell without the device getting in the way.
7
When the device is fully assembled, it should appear as it does in the photo below.For convenience, rotate the inhalation piece so you can best see the indicator lights and display screen, which provide important prompts during your treatment.
Turning On the Inhalation Device
1
Connect your device to one (1) of the power source options by plugging one end of the power cord into the back of the inhalation device and the other end into the power source.If using the AC wall plug, make sure to plug the output cable into the device before plugging adapter into the power source.
If using the rechargeable battery, make sure it is not also plugged into the AC wall plug.
2
To turn on the device, press and hold the ON/OFF button for approximately three (3) seconds. When you hear a short beep and the yellow status light is illuminated, release the ON/OFF button. Remember to press the center of the ON/OFF button when powering the device on or off.When the power is on, the display screen will show the last number of breaths programmed and a yellow light will appear next to the screen.
Make sure the number matches the prescribed number of breaths for that treatment session. If it does not match, see the next page for instructions on setting the number of breaths in a treatment session.
Setting the Number of Breaths in a Treatment Session
You will inhale TYVASO during four (4) treatment sessions each day. During each treatment session, you will take a series of breaths through the mouthpiece of the TYVASO Inhalation System.
Your doctor will prescribe the number of breaths you should inhale in each treatment session.
You should record the number of breaths in your Treatment Tracker.
1
Make sure the device is powered off. To power off the device, press and hold the ON/OFF button for three (3) seconds. When you hear a short beep and the display screen turns off, release the ON/ OFF button.To set the number of breaths, press and hold both the START/STOP and ON/OFF buttonsat the same timeuntil the display flashes and the device emits three (3) short beeps.
The flashing display indicates the inhalation device is in breath programming mode. You cannot begin a treatment while the display is flashing.
2
To increase the number of breaths press the+(ON/OFF) button.To decrease the number of breaths press the(START/STOP) button.
Remember to press in the center of the buttons.
3
Once you have entered your prescribed number of breaths, remove your hands from the device and wait approximately 15 seconds.After approximately 15 seconds, the display will stop flashing and the device will emit three (3) short beeps, indicating that it has saved the new number of breaths. The new number of breaths will appear on the display.
Make sure the number of breaths on the display matches the number of breaths in your prescription. If the numbers do not match, repeat steps 1-3.
Inhaling Your Medicine, TYVASO(treprostinil) Inhalation Solution
You will inhale TYVASO during four (4) treatment sessions each day. During each treatment session, you will take a series of breaths through the mouthpiece of the TYVASO Inhalation System.
Inhalation Tips
Technique: ⮝
When breathing each TYVASO treatment, be sure to keep the device level, directing the flow of medicine into the throat and not toward the roof of the mouth.
Seal your lips around the mouthpiece to ensure that you can inhale the full amount of TYVASO after it is produced by the device.
Inhalation: ⮝
Each breath should last approximately three (3) seconds, breathing "normal full breaths." Do not hold your breath. Exhale normally and prepare for the next breath.
1
Hold the device upright as shown below. Make sure you can see the display screen and lights clearly and that your hands do not cover the display screen or lights while holding device. If the inhalation piece or mouthpiece block your view of the display screen or lights, move the inhalation piece so you can best see them.2
Perform steps A-G to complete one (1) treatment session.
Follow the instructions exactly to make sure you receive the correct medication dose.
A B C D Press the START/STOP button to begin treatment. The status light turns green and the device emits two (2) short beeps. While the device emits one (1) long beep, exhale completely. After the device emits a short beep and while the inhalation indicator light is flashing green, place your lips securely around the mouthpiece and inhale slowly for the duration of the beep (at least three (3) seconds). Exhale normally, mark a circle in the Treatment Tracker and prepare for the next breath.
E F G Repeat steps B through D for the number of prescribed breaths and until the display counts down to "00". After the final breath, the display screen will show "00" then "En," indicating the treatment session is complete.
Check the number of breaths you inhaled on the Treatment Tracker.To turn off the device, press and hold the ON/OFF button for three (3) seconds and then release.
If the device is left in "En" mode for more than 60 seconds, it will turn off automatically.3
To pause the treatment between breaths, press the START/STOP button. The display screen will show "PA."To resume treatment, press START/ STOP again. "PA" will disappear and the display screen will show the number of breaths remaining.
If the device is disconnected from its power source for any reason (for example, a power failure), reconnect the device to a power source. Follow the instructions on page 13 to turn on the device. The display will show how many breaths are left in that treatment session. Press the START/STOP button to continue your treatment session.
Storing the TYVASO Inhalation System Between Treatment Sessions
If you have more treatment sessions left in the day, perform the following steps.
If you have completed your last treatment session of the day, skip toCleaning and Maintenance of the TYVASO Inhalation System(see page 24).
Be sure to pack all parts, including a backup power supply, in the carry case whenever transporting your device.
1
Disconnect the device from its power source.2
Remove both filter shells.Do NOT remove the filter membranes from filter shells until after the last treatment session of the day.
3
Remove the mouthpiece.4
Remove the inhalation piece.5
Leave the dome assembly and medicine cup (with the medicine still in it) connected to the device.6
Insert a plug into each of the open holes on the dome assembly to prevent the medicine from spilling out.7
The inhalation device with the plugged dome assembly and all the accessories can be stored in the carrying case between treatment sessions.Cleaning and Maintenance of the TYVASO Inhalation System
End of Day Cleaning of the Accessories
1
Disconnect the device from the power source.2
Remove both filter shells.3
Open the filter shells by twisting in opposite directions.Remove and discard the used filter membranes.
4
Remove the mouthpiece.5
Remove the inhalation piece.6
Remove the dome assembly by turning it counter-clockwise (to the left). The medicine cup should stay attached to the dome assembly.7
Remove the medicine cup by gently squeezing on the sides where it is attached to the dome assembly. Empty the medicine cup into a sink or waste basket, then discard the medicine cup.Be careful not to spill the medicine when removing or discarding the medicine cup.
8
Empty the distilled water from the chamber and let the inhalation device air dry upside down. You can wipe the chamber with a soft cloth or paper towel to collect water.9
Clean the accessories (pictured below) by hand in mild, soapy, warm water, then rinse them thoroughly with water. Allow accessories to air dry.10
Once all the items are dry, the filter shells, inhalation piece, mouthpiece, dome assembly, and inhalation device can be stored in the carrying case until the next day's treatment sessions.Weekly Cleaning
- Once a week, use a clean cloth to wipe the interior of the inhalation device chamber, be sure to wipe the disc in the bottom of the device. You may wipe the exterior of the device with a damp cloth if the lights or buttons become difficult to see. Proper cleaning will help to avoid corrosion and leaks and keep your device working properly.
Monthly Refill Kit
- Once a month, you will receive a refill kit that will come with a new set of accessories from your specialty pharmacy provider. Inspect the shipment to be sure all parts are included (see page 7). Once the new kit has arrived, discard the used dome assembly, inhalation piece, mouthpiece, and two (2) filter shells. Do not recycle the used accessories.
Device Replacement
- The inhalation device should be replaced every two (2) years from your first day of use. Replacement inhalation devices will be supplied by your specialty pharmacy provider.
Charging Your TYVASO Inhalation System
Rechargeable Battery
The rechargeable battery is supplied with its own instructions for use. Refer to these instructions for more information.
- Your TYVASO Inhalation System is supplied with a portable, rechargeable battery. DoNOTuse other batteries.
- Your battery can only be charged by using one (1) of the AC wall plugs that comes with your inhalation device.
- To check the battery's voltage level, press and hold the blue button on the front of the battery. You can only check the battery's voltage level when the battery is not plugged into a power source.
The light below the button will turn on and indicate the battery's voltage level. A red light indicates the battery needs to be charged. A green light indicates the battery is ready to operate the device.
- To charge the battery, connect the AC wall plug to the battery pack and plug the AC wall plug into an outlet.
A yellow light on the front of the battery will turn on, indicating that the battery is charging.
- Your battery may take up to 40 hours to fully charge. It is not possible to use the TYVASO Inhalation System with the battery while it is recharging.
A fully charged battery will typically last up to 200 inhalations. A battery charged for one (1) night (about 10 hours) will typically last up to one (1) day of therapy (about 40 inhalations).
- You should connect the charged battery to the TYVASO Inhalation System only for your treatment. When using the battery pack to power the device, make sure the battery is not plugged into a power source.
- After your treatment session is complete, remove the power plug of the battery from the device.
- Charge the battery whenever you are not using it to power the inhalation device.
- Always have your AC wall plug or 12V DC adapter available for backup, in case the battery is not charged.
Troubleshooting the TYVASO Inhalation System
Problem Possible causes Corrective actions Low battery (LB)
- Low battery
- Unplug the battery from the device. Charge the battery by attaching it to the AC wall plug and outlet.
- Use an alternative power source, such as the AC wall plug or 12V DC adapter, for treatment.
- Defective adapter (AC wall plug or 12V DC adapter)
- Ensure that the plug is properly connected to an outlet.
- AC wall plug is still plugged into battery and battery is connected to device.
- Turn off device (see page 14).
- Disconnect AC wall plug from battery.
- Check battery status, following instructions on page 28.
- If device is properly powered and still does not function, contact your specialty pharmacy provider for a replacement.
Low hydrogen (LH)
- Device chamber is empty or distilled water level in the device chamber is too low.
- Unplug the device from its power source.
Remove the dome assembly carefully, making sure not to spill its medicine. Empty the device chamber then refill it with distilled water (see page 8) and reconnect the dome assembly (see page 10).
- The distilled water you are using is too purified
- Empty device chamber. Add one (1) teaspoon of tap water to the water fill cup. Fill cup with distilled water up to level between the two arrow markings on cup (see page 8). Pour cup's contents into device chamber.
- The sensor has a thin layer of build-up
- Clean sensor and interior surfaces of water chamber with a clean cloth.
- If device is properly powered and still does not function, contact your specialty pharmacy provider for a replacement.
No medicine comes out of the device during a treatment session
- No TYVASO(treprostinil) Inhalation Solution in the medicine cup
- Unplug the device from its power source. Fill medicine cup with one (1) ampule of TYVASO.
- Damaged medicine cup
- Unplug the device from its power source. Replace the medicine cup.
- Distilled water level in the device chamber is too high
- Unplug the device from its power source. Empty the device chamber then refill it with 45 mL of distilled water.
- Multiple medicine cups attached to the dome assembly
- Unplug the device from its power source. Remove and dispose of all medicine cups in the device. Insert a single, new medicine cup into device chamber and fill with one (1) ampule of TYVASO.
Difficult to breathe in medicine through the mouthpiece
- Filter membrane is clogged
- Unplug the device from its power source. Replace filter membrane (see page 11).
No "click" was heard when attaching the dome assembly
- No medicine cup in the chamber of the device
- Insert an empty medicine cup into the chamber of the device and fill it with one (1) ampule of TYVASO.
- Multiple medicine cups attached to the dome assembly
- Unplug the device from its power source. Remove and dispose of all medicine cups in the device. Insert a single, new medicine cup into device chamber and fill with one (1) ampule of TYVASO.
- Dome assembly is not securely in place
- Unplug the device from its power source. Align the circle on the side of the dome assembly with the circle on the side of the device. Push down and screw the dome assembly onto the device clockwise (right) until you hear a click, indicating the dome assembly is fully connected to the medicine cup.
Loss of power during treatment
- Device is disconnected from its power source
- Reconnect the device to a power source and press the ON/OFF button to turn on the device. The display will show how many breaths are left in that treatment session. Press the START/STOP button to continue your treatment session.
- Power source is temporarily disrupted (for example, electricity interruption due to a storm)
- Reconnect the device to a power source and turn on the device (see page 13). The display will show how many breaths are left in that treatment session. Press the START/ STOP button to continue your treatment session.
Inhalation Device
Model TD-100/A Size 98 66 105 mm Weight, inhalation device 280 g (9.9 ounces) Types of power supply AC wall plug
12V DC adapter
Rechargeable batteryPower input 12V DC, 1.5A maximum Operating power consumption 18 Watt maximum Ultrasonic frequency 2.4 MHz (nominal) Nebulization rate 0.50 - 0.55 mg/min (0.9% Saline) Medicine cup capacity 6 mL, nominal Contact fluid chamber capacity 45 mL, nominal Electric protection class II Type B Storage temperature/humidity -5 to 40 C/20-80% relative humidity Operating temperature/humidity 15 to 25 C/40-75% relative humidity Packaging Dimensions(Approximate Length Width Height)
Patient Starter Kit (PSK) 12.2" 14.3" 16.0" Monthly Refill Kit (MRK) 9.9" 6.1" 16.1" Institutional Starter Kit (ISK) 12.2" 14.3" 16.0" TYVASO Mass and Particle Specifications for 9 breaths
- *
- n=108 data points from r=3 inhalation devices. Each data point was 9 breaths.
- n=216 data points from r=6 inhalation devices. Each data point was 1 breath.
Mass Median Aerosol Diameter (MMAD)* mean = 2.0 m
SD = 0.3Total Emitted Dose per Breath mean = 6.0 g
SD = 0.4Total Aerosol Mass* mean = 58 g
SD = 5.9Total Respirable Dose* mean = 44.6 g
SD = 3.5Respirable Fraction* mean = 73%
SD = 5%Geometric Standard Deviation (GSD)* mean = 2.6 m
SD = 0.4Accessories
Note: Part number subject to change. ON-110HPA Rechargeable battery ON-100Z 12V DC adapter ON-100N-US AC wall plug ON-102/1/C Medicine cup, Quantity-16 ON-109 Filter membranes ON-120/C Plugs ON-101/C Filter shell TD-103/C Dome assembly with baffle plate ON-104/C Inhalation piece ON-105/C Mouthpiece TD-118 Water level cup TD-153 Carrying case TD-155 Distilled water carrier Glossary
Accessories: ⮝
Parts of the TYVASO Inhalation System. See pages 6 and 7.Ampule:A sealed, lightweight clear plastic vial containing a 1-day supply of TYVASO(treprostinil) Inhalation Solution.
Control Light For Inhalation: ⮝
A green LED on the top surface of the inhalation device that signals when you should inhale.
Baffle Plate: ⮝
A blue plastic piece that is inside the dome assembly. The baffle plate helps turn TYVASO into particles that are the correct size to inhale.
Display Screen: ⮝
A small area on the inhalation device that displays number and letter prompts to guide you through your treatment sessions.
Distilled Water: ⮝
Water that is highly purified so that it contains only essential elements.
Dome Assembly: ⮝
The plastic accessory that contains the baffle plate and connects the mouthpiece, inhalation piece, and filter shells to the base of the inhalation device.
Filter Membrane: ⮝
The white pad that goes into the filter shells.
Filter Shells: ⮝
Plastic accessories that hold the filter membranes.
Inhalation Piece: ⮝
The plastic accessory that connects the mouthpiece with the dome assembly.
Inhalation Device: ⮝
The base of the TYVASO Inhalation System to which the accessories connect. The inhalation device contains the display screen and lights.Inhale:How you will breathe in TYVASO with the TYVASO Inhalation System.
Medicine Cup: ⮝
The disposable plastic cone-shaped cup into which TYVASO is poured. The medicine cup fits inside the inhalation device chamber.
Mouthpiece: ⮝
The plastic part that you will breathe through (using your mouth) to inhale TYVASO.
On/off Button: ⮝
A manually activated control on the front of the device that switches between fully on and fully off power states.Plugs:Plastic accessories that are inserted into the openings of the dome assembly between treatment sessions. Plugs help keep TYVASO from spilling if the inhalation device tips over.
Prompts: ⮝
The audio and visual signals that help guide you through the treatment sessions.Sensor:The silver object on the inside wall of the device chamber. The sensor must be covered with distilled water for the TYVASO Inhalation System to function properly.
Status Light: ⮝
A multicolored LED on the front of the inhalation device that indicates the device's operational status.
Start/stop Treatment Button: ⮝
A manually activated control on the front of the device that begins or pauses treatment.
Specialty Pharmacy Provider: ⮝
A pharmacy that carries only specialized medicines and medical devices. Your specialty pharmacy provider is a good source of information about TYVASO and the TYVASO Inhalation System.
Treatment Session: ⮝
One (1) of four (4) daily sessions during which you will take TYVASO with a specific number of inhalations.TYVASO:The prescription medicine that you will use with the TYVASO Inhalation System.
For All Inquiries Relating To Service Or Warranty For Your Tyvaso Inhalation System, Contact Your Specialty Pharmacy Provider. You Should Have The Following Information Available: ⮝
- Device serial number (located on bottom of TYVASO Inhalation System)
- Date TYVASO Inhalation System was acquired
- Nature of the problem and any steps taken to fix it
Graphics in IFU are for representation only. Images may not be shown to scale
TYVASO
INHALATION SYSTEM
Instructions for UseTYVASO Inhalation Solution is for prescription use only.
TYVASO is a registered trademark of United Therapeutics Corporation.
Literature Issued 2016-07-30
For further questions and information, or to report an adverse reaction, please call 1-877-UNITHER (1-877-864-8437).
Emergency contact information
Clinician: ___________________________________
Nurse educator: ______________________________
Specialty pharmacist: __________________________
United Therapeutics: ___________________________
Distributed By: ⮝
United Therapeutics Corporation
Research Triangle Park, North Carolina 27709TYVASO
(treprostinil)
INHALATION
SOLUTION2016, United Therapeutics Corporation. All rights reserved.
RTP-1-00052 Rev. ETYVASO
INHALATION SYSTEMInstructions for Use Manual
TYVASO
(treprostinil)
INHALATION
SOLUTIONContents
Overview of your TYVASO Inhalation System 4 Introduction 6 Safety and general instructions 8 Buttons, indicators, and markings 10 Inhalation device display screens 16 Programming your TYVASO Inhalation System before use 18 Charging device before use 20 Setting your prescribed dose 22 Adjusting device's audio volume 24 Preparing and using your TYVASO Inhalation System for daily treatments 26 Prepare a proper environment 28 Gather supplies 29 Fill water chamber and medicine cup 32 Assemble inhalation device 35 Power on inhalation device 40 Inhale your medicine 42 Cleaning and Storing your TYVASO Inhalation System 46 Storing between sessions during the day 48 End of day cleaning 52 Recharging the Battery 57 Weekly Cleaning 59 Monthly Refill Kit 60 Replacing your devices 61 Help / More information about your TYVASO Inhalation System 62 Troubleshooting 64 Specifications 76 Electromagnetic compatibility (EMC) 79 Glossary 87 Warranty information 90 Overview of your TYVASO Inhalation System
Section overview
This section introduces you to your TYVASO Inhalation System and provides important safety information about using your system.
Delivering Treatments: ⮝
- Read the instructions carefully and completely to prevent damage to your TYVASO Inhalation System and help you get the best results.
- This device should only be used on the order of your doctor or licensed healthcare practitioner.
- Conduct only the number of treatment sessions and inhalations you have been prescribed.
- Ensure the breath counter is correctly programmed prior to beginning a treatment (see page 22).
- Turn off the device when not in use.
- Do not use the device with an anesthetic breathing system or ventilator breathing system.
- Use only the supplies provided in the Starter Kit and Monthly Refill Kit for correct device function.
Handling The Device: ⮝
- Do not peel or remove the labels from the device.
- Do not drop the device.
- The device does not include internal, replaceable parts. Do not attempt to open the device, modify the device, or remove device labeling.
Your Environment: ⮝
- Do not leave the device alone with a small child.
- Do not immerse the device in water or other liquids, or place in dishwasher.
- Do not place any system components in a microwave, conventional oven, or dishwasher.
- Do not use the device near flammable liquids and materials or heated surfaces.
- Do not place the device or use the device in the presence of strong electric or magnetic fields (eg, microwave oven, magnetic imaging equipment).
- Wireless communications equipment (eg, cell phone) can affect operation of the device and should be kept at least a distance of 3.3 meters (about 11 feet) away while using the device.
- If the device performance is affected by exposure to any conditions listed here, see theTroubleshootingsection, or contact your healthcare provider or specialty pharmacy provider.
C: Buttons, indicators, and markings Inhalation device
Inhalation indicator lights
Lights on top of device flash green when you should inhale.
On/Off, Start/Pause (blue) button
Press andholdto power device on or off. Once device is on, pressand immediatelyrelease (do not hold down) to start or pause treatment.
Device Display
Provides instructions and device information.
Run / Program switch
Slide up to Run mode when you are ready to deliver your dose. Slide down to Program mode to program the number of breaths for your dose.
Volume / Breaths toggle button
When set to Run mode, push+to increase beeping volume, or push-to decrease beeping volume.
When set to Program mode, push+to increase the number of breaths, or push-to decrease the number of breaths required for each dose.
Power status light
Lights green when power is connected and battery is charging.
Power port
Port for plugging into a power source using the AC wall plug.
Additional device markings Manufacturer. Indicates the medical device manufacturer.
(Symbol 5.1.1 of ANSI/AAMI/ISO 15223-1: 2012 Medical devices - symbols to be used with medical devices labels, labeling, and information to be supplied - part 1: general requirements)Equipment should not be disposed of in the trash.
(Figure 1 of BS EN 50419:2006 - Marking of Electrical and Electronic Equipment in accordance with Article 11(2) of Directive 2002/96/EC (WEEE))Catalogue number. Indicates the manufacturer's catalogue number so that the medical device can be identified. (Symbol 5.1.6 of ANSI/AAMI/ISO 15223-1: 2012 Medical devices - symbols to be used with medical devices labels, labeling, and information to be supplied - part 1: general requirements) Serial number. Indicates the manufacturer's serial number so that a specific medical device can be identified. (Symbol 5.1.7 of ANSI/AAMI/ISO 15223-1: 2012 Medical devices - symbols to be used with medical devices labels, labeling, and information to be supplied - part 1: general requirements) Consult instructions for use. Please read the accompanying instructions and labels for important information regarding the TYVASO Inhalation System. (Symbol 5.4.3 of ANSI/AAMI/ISO 15223-1: 2012 Medical devices - symbols to be used with medical devices labels, labeling, and information to be supplied - part 1: general requirements) The TYVASO Inhalation System has a Type BF Applied part. Type BF Applied parts comply with specific requirements to provide protection against shock and are not suitable for direct cardiac applications.
(Symbol 5333 of IEC 60417 Database Snapshot - Graphical symbols for use on equipment)The TYVASO Inhalation System requires a 14V DC power supply. Use only the power supply intended for the TYVASO Inhalation System.
(Direct Current, Symbol 5031 of IEC 60417 Database Snapshot - Graphical symbols for use on equipment)The TYVASO Inhalation System complies with the requirements of Protection Class II. Class II equipment provides additional precautions, over and above basic insulation, to provide protection against electric shock. (Class II equipment, Symbol 5172 of IEC 60417 Database Snapshot - Graphical symbols for use on equipment) The TYVASO Inhalation Device provides level 2 solid particle protection and level 2 liquid ingress protection per IEC 60529 specifications. The TYVASO Inhalation System should only be used on the order of your doctor or licensed healthcare provider. (Symbol statement as provided under 21 CFR 801.109(b)(1)) Power stand by. Indicates the control for powering on and off the TYVASO Inhalation System. ("On" / "Off", Symbol 5010 of IEC 60417 Database Snapshot - Graphical symbols for use on equipment) Start/Pause. Indicates the control for starting a treatment session once the device is powered on, and for pausing a treatment once a treatment session has started. (Play and Pause, Symbols 5107B and 5111B, respectively, of IEC 60417 Database Snapshot - Graphical symbols for use on equipment)
D: Inhalation device display screens Splash screen
Device name and software versionLast Treatment
Time since your last treatmentProgram Breaths
Number of breaths set in Program modeAdjust Volume
Audio volume level set in Run modeBreaths Left
Number of breaths left in a current doseExhale
Prompt to exhale during a doseInhale
Prompt to inhale during a doseDone
Treatment session is completePause
You have paused a treatment sessionCall Support
Device is not working, call your specialty pharmacy provider for supportAdd Water
Wrong or missing fluid in water chamberCharge Battery
Battery not charged enough to deliver treatmentStatus icons
Icons that might appear at bottom of the screenProgramming your TYVASO Inhalation System before use
Section overview
This section provides instructions for charging your device, setting your dose, and adjusting the device's audio volume before you use the device for a treatment.
Important: ⮝
A new device might not be fully charged when you receive it. Always charge the device before you first use it. You can also charge the device overnight, when not in use and in between uses.Plug the AC wall plug's white connector into the port on the back of the inhalation device. Then, plug the AC wall plug into the wall outlet.
The power status light above the port will light green when properly plugged in.
2. Check the battery's status
Make sure the Run / Program switch is set to Run. Press andholdthe blue button to power on the device.
The battery icon at the bottom of the screen indicates battery status.
When you are done checking the battery status, press andholdthe On/Off button until the display screen shuts off (note: letting the button go before the screen shuts off will start a treatment session).
If there is not enough charge to conduct a treatment session, "Charge battery" appears on screen.
B: Setting your prescribed dose Your doctor will prescribe the number of breaths you should take in each treatment session. You should program this number into the inhalation device before you use the device.
1. Switch to Program
Slide the Run / Program switch on the side of the device down to Program mode. In Program mode you enter the prescribed number of breaths for each dose. You cannot begin a treatment in Program mode.
2. Power on
Press andholdthe On/Off button until the display screen turns on. The Program Breaths screen appears. The number of breaths currently set for each treatment session will flash.
3. Set breaths
Use the Volume / Breaths toggle button to enter your prescribed number of breaths onto the program screen.
4. Switch to Run
Slide the Run / Program switch up to Run mode. Make sure your new breath count appears on screen.
5. Power off
Press andholdthe On/Off button until the display screen shuts off (note: letting the button go before the screen shuts off will start a treatment session).
Note: You will not need to program the breath count again, unless your prescribed number of breaths changes.
C: Adjusting device's audio volume You can use the Volume / Breaths toggle button to adjust the volume of the audible signals (beeps) that the device provides as feedback during treatment sessions.
1. Switch to Run
Slide the Run / Program switch up to Run mode, if it is not in this position already.
2. Power on
Press andholdthe On/Off button until the display screen turns on, if it is not already turned on. The programmed number of breaths will appear with the words "Breaths left" and the battery icon at the bottom.
3. Adjust volume
With the Run / Program switch in the Run position, press the Volume / Breaths toggle button to access the Adjust Volume screen. Push + on the Volume / Breaths toggle button to increase beeping volume, or push - to decrease beeping volume.
audio off mid-level volume maximum volume 4. Power off
After adjusting the beeping volume up or down, the screen will display your new setting for a couple of seconds then return to the screen displaying the breaths left.
Press andholdthe On/Off button until the display screen shuts off (note: letting the button go before the screen shuts off will start a treatment session).
Preparing and using your TYVASO Inhalation System for daily treatments
Section overview
This section provides instructions for preparing and using your TYVASO Inhalation System for daily treatments.
What Is Covered In This Section: ⮝
A: Prepare a proper environment 28 B: Gather supplies 29 C: Fill water chamber and medicine cup 32 D: Assemble inhalation device 35 E: Power on inhalation device 40 F: Inhale your medicine 42
Caution: ⮝
If any medicine from the ampule spills on your hands, wash your hands right away. Medicine contact with the skin can cause irritation.5. Squeeze ampule
Point the ampule straight down toward the medicine cup's center to avoid spills.
Gently squeeze the medicine out of the ampule into the medicine cup. Squeeze until it is empty. Check to see that all of the medicine is in the medicine cup.
D: Assemble inhalation device
The Battery Icon At The Bottom Of The Screen Indicates Battery Status: ⮝
- "Charge battery" appears on screen if there is not enough charge to conduct a treatment session.
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What You Will Need: ⮝
Access to a phone (to contact support if troubleshooting steps do not resolve the problem) A clean place to work with the device TYVASO Inhalation Device or supplies, as needed
For Further Support, You Can: ⮝
- Fill out and refer to your emergency contact information on the back of this Instructions for Use manual.
- Call 1-877-UNITHER (1-877-864-8437) for questions and information, or to report an adverse reaction.
A: Troubleshooting
Problem Possible causes Corrective actions Charge Battery screen appears Low battery Charge the device battery by attaching the AC wall plug to an outlet. You can conduct a treatment session with the device plugged in. AC wall plug not properly connected Ensure that the plug adapter piece (the detachable piece with the metal prongs) is securely attached to the AC wall plug. Then, make sure the AC wall plug is properly connected to an outlet and device. The status lights on the back of the AC wall plug and device should light green. You can conduct a treatment session with the device plugged in. AC wall plug is defective Use the replacement AC wall plug. Confirm that status light on AC wall plug is green when plugged in. You can conduct a treatment session with the device plugged in. If device still does not function after taking corrective actions listed above, contact your specialty pharmacy provider for assistance. Screen does not turn on Device battery is completely empty Charge the device battery by attaching the AC wall plug to an outlet. You can conduct a treatment session with the device plugged in. AC wall plug not properly connected Ensure that the plug adapter piece (the detachable piece with the metal prongs) is securely attached to the AC wall plug. Then, make sure the AC wall plug is properly connected to an outlet and device. The status lights on the back of the AC wall plug and device should light green. You can conduct a treatment session with the device plugged in. AC wall plug is defective Use the replacement AC wall plug. Confirm that status light on AC wall plug is green when plugged in. You can conduct a treatment session with the device plugged in. If device still does not function after taking corrective actions listed above, contact your specialty pharmacy provider for assistance. Call Support screen appears Temporary device failure. Unplug device, if plugged in, and power off device. Power on device and check that Call Support screen does not reappear. Continue treatment. If device still does not function after taking corrective actions listed above, contact your specialty pharmacy provider for assistance. Loss of power during treatment Device is disconnected from power source and battery is empty Reconnect device to power source and confirm the power status light on back of device is green (battery is charging). Press andholdthe blue On/Off button to turn on the device. The display will show how many breaths are left in that treatment session. Pressand immediatelyrelease (do not hold down) the blue button again to continue your treatment session. Power source is temporarily disrupted (for example, electricity interruption due to a storm) Reconnect device to power source and confirm the power status light on back of device is green (battery is charging). Press andholdthe blue On/Off button to turn on the device. The display will show how many breaths are left in that treatment session. Pressand immediatelyrelease (do not hold down) the blue button again to continue your treatment session. If device still does not function after taking corrective actions listed above, contact your specialty pharmacy provider for assistance. Add Water screen appears Water chamber is empty or distilled water level is too low. Unplug device, if plugged in, and power off device. Remove dome assembly (making sure not to spill medicine) and place it aside, keeping it upright. Then empty water chamber.
Refill water chamber with distilled water using water level cup (see page 32). Reassemble device. Power the device on and continue treatment.The distilled water is too pure. Unplug device, if plugged in, and power off device. Remove dome assembly (making sure not to spill medicine) and place it aside, keeping it upright. Then empty water chamber.
Add 1 teaspoon of tap water to the water level cup. Fill rest of cup with distilled water up to level between the 2 arrow markings on cup (see page 32). Pour cup's contents into water chamber. Reassemble device. Power the device on and continue treatment.Water level sensors have a thin layer of build-up Unplug device, if plugged in, and power off device. Remove dome assembly (making sure not to spill medicine) and place it aside, keeping it upright. Then empty water chamber.
Clean sensors and interior surfaces of water chamber with a clean cloth. Refill water chamber with distilled water using water level cup (see page 32). Reassemble device. Power the device on and continue treatment.If device still does not function after taking corrective actions listed above, contact your specialty pharmacy provider for assistance. No "click" (or crunch) was heard when attaching the dome assembly No medicine cup in the water chamber of the device Unplug device, if plugged in, and power off device. Place an empty medicine cup into the water chamber of the device and fill it with 1 ampule of TYVASO. Reassemble device. Power the device on and continue treatment. Multiple medicine cups attached to the dome assembly Unplug device, if plugged in, and power off device. Remove and dispose of all medicine cups in the device. Place a single, new medicine cup into device water chamber and fill with 1 ampule of TYVASO. Reassemble device. Power the device on and continue treatment. Dome assembly is not securely in place Unplug device, if plugged in, and power off device.
Align the raised circle on the side of the dome assembly with the raised circle on the side of the device.Push down and screw the dome assembly onto the device clockwise (right) until the filter shell port is tight and pointed to the back of the device and the raised circles line up again. You will hear clicks (or crunch sound) as the dome assembly presses down on the medicine cup. Reassemble device. Power the device on and continue treatment. If device still does not function after taking corrective actions listed above, contact your specialty pharmacy provider for assistance. No medicine comes out of the device during a treatment session No TYVASO(treprostinil) Inhalation Solution in the medicine cup Unplug device, if plugged in, and power off device. Fill medicine cup with 1 ampule of TYVASO. Reassemble device. Power the device on and continue treatment. Damaged medicine cup Unplug device, if plugged in, and power off device. Remove and dispose of the medicine cup in the device. Empty the water chamber then refill it with 45 mL of distilled water (see page 32). Place a single, new medicine cup into water chamber and fill with 1 ampule of TYVASO. Reassemble device. Power the device on and continue treatment. Distilled water level in the water chamber is too high Unplug device, if plugged in, and power off device. Remove dome assembly (making sure not to spill medicine) and place it aside, keeping it upright. Empty the water chamber then refill it with 45 mL of distilled water (see page 32). Reassemble device. Power the device on and continue treatment. Multiple medicine cups attached to the dome assembly Unplug device, if plugged in, and power off device. Remove and dispose of all medicine cups in the device. Place a single, new medicine cup into water chamber and fill with 1 ampule of TYVASO. Reassemble device. Power the device on and continue treatment. If device still does not function after taking corrective actions listed above, contact your specialty pharmacy provider for assistance. Difficult to breathe in medicine through the mouthpiece Filter membrane is clogged Unplug device, if plugged in, and power off device. Replace both filter membranes (see page 37). Reassemble device. Power the device on and continue treatment. If device still does not function after taking corrective actions listed above, contact your specialty pharmacy provider for assistance.
B: Specifications
Inhalation Device Model TD-300/A Size 3.5" 3.2" 4.7" (90 82 120 mm) Weight, inhalation device 365 g (12.8 oz) Types of power supply AC wall plug, 120 V, 60 Hz Power input 14 V DC, 1.1 A maximum Operating power consumption 18 Watt maximum Ultrasonic frequency 2.4 MHz (nominal) Nebulization rate 0.50 - 0.55 mg/min (0.9% Saline) Medicine cup capacity 6 mL, nominal Water chamber capacity 45 mL, nominal Electric protection class II, Type BF Storage temperature/humidity 15 to 30 C/20-80% relative humidity Operating temperature/humidity 15 to 25 C/40-75% relative humidity A-weighted sound pressure level 75 dBA (1 m), maximum
Packaging Dimensions (Approximate Length Width Height) Patient Starter Kit (PSK) 12.2" 14.3" 16.0" Monthly Refill Kit (MRK) 9.9" 6.1" 16.1" Institutional Starter Kit (ISK) 12.2" 14.3" 16.0"
TYVASO Mass and Particle Specifications for 9 breaths
- *
- n=108 data points from r=3 inhalation devices. Each data point was 9 breaths.
- n=216 data points from r=6 inhalation devices. Each data point was 1 breath.
Mass Median Aerosol Diameter (MMAD)* mean = 2.0 m
SD = 0.3Total Emitted Dose per Breath mean = 6.0 g
SD = 0.4Total Aerosol Mass* mean = 58 g
SD = 5.9Total Respirable Dose* mean = 44.6 g
SD = 3.5Respirable Fraction* mean = 73%
SD = 5Geometric Standard Deviation (GSD)* mean = 2.6
SD = 0.4
Accessories Note: Part number subject to change. TD-300N-US AC wall plug ON-102/1/C Medicine cup, Quantity-16 ON-109 Filter membranes ON-120/C Plugs ON-101/C Filter shell TD-103/C Dome assembly with baffle plate ON-104/C Inhalation piece ON-105/C Mouthpiece TD-118 Water level cup TD-158 Carrying case TD-155 Distilled water carrier
C: Electromagnetic compatibility (EMC) The Tyvaso Inhalation System has been tested and found to comply with the electromagnetic compatibility (EMC) limits for medical devices according to IEC 60601-1-2: (2007). Compliance is intended to provide reasonable protection against harmful interference in a typical user environment.
Table 1, Table 2 and Table 3 document the intended EMC use environment and established compliance levels for the Tyvaso Inhalation System. To ensure the intended performance, use the system in the environments described in these tables.
The Tyvaso Inhalation System is intended for use in the electromagnetic environment specified in this section.
Table 1: Guidance and manufacturer's declaration - electromagnetic emissions Guidance and manufacturer's declaration - electromagnetic emissions The Tyvaso Inhalation System is intended for use in the electromagnetic environment specified below. The customer or the user of the Tyvaso Inhalation System should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 Group 1 The Tyvaso Inhalation System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class B The Tyvaso Inhalation System is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations/flicker emissions IEC 61000-3-3 Complies
Table 2: Guidance and manufacturer's declaration electromagnetic immunity NOTEUTis the a.c. mains voltage prior to application of the test level.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
- *
- Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Tyvaso Inhalation System is used exceeds the applicable RF compliance level above, the Tyvaso Inhalation System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Tyvaso Inhalation System.
- Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
Guidance and manufacturer's declaration electromagnetic immunity The Tyvaso Inhalation System is intended for use in the electromagnetic environment specified below. The customer or the user of the Tyvaso Inhalation System should assure that it is used in such an environment. Immunity test IEC 60601 Test level Compliance level Electromagnetic environment - guidance Electrostatic discharge (ESD)
IEC 61000-4-28 kV contact
15 kV air8 kV contact
15 kV airFloors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Electrical fast transient/burst
IEC 61000-4-42 kV for power supply lines
1 kV for input/output lines2 kV for power supply lines
1 kV for input/output linesMains power quality should be that of a typical commercial or hospital environment. Surge
IEC 61000-4-51 kV line(s) to line(s)
2 kV line(s) to earth1 kV line(s) to line(s)
2 kV line(s) to earthMains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-110 %UT(100 % dip inUT) for 0,5 cycle
0 %UT(100 % dip inUT) for 1 cycle
70 %UT(30 % dip inUT) for 25/30 cycles
0 %UT(100 % dip inUT) for 250/300 cycle0 %UT(100 % dip inUT) for 0,5 cycle
0 %UT(100 % dip inUT) for 1 cycle
70 %UT(30 % dip inUT) for 25/30 cycles
0 %UT(100 % dip inUT) for 250/300 cycleMains power quality should be that of a typical commercial or hospital environment. If the user of the Tyvaso Inhalation System requires continued operation during power mains interruptions, it is recommended that the Tyvaso Inhalation System be powered from an uninterruptible power supply or the internal battery. Power frequency (50/60 Hz) magnetic field
IEC 61000-4-830 A/m 30 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-33 Vrms 150 kHz to 80 MHz
10 V/m 80 MHz to 2.6 GHz3 Vrms 150 kHz to 80 MHz
10 V/m 80 MHz to 2.6 GHzPortable and mobile RF communications equipment should be used no closer to any part of Tyvaso Inhalation System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
d= 1.2P
d= 1.2P80 MHz to 800 MHz
d= 2.3P800 MHz to 2.5 GHz
wherePis the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer anddis the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey*, should be less than the compliance level in each frequency range.
Interference May Occur In The Vicinity Of Equipment Marked With The Following Symbol: ⮝
Table 3: Manufacturer's Declaration Recommended separation distances between portable and mobile communications equipment and the Tyvaso Inhalation System For transmitters rated at a maximum output power not listed above, the recommended separation distancedin meters (m) can be estimated using the equation applicable to the frequency of the transmitter, wherePis the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.Recommended separation distances between portable and mobile RF communications equipment and the Tyvaso Inhalation System The Tyvaso Inhalation System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Tyvaso Inhalation System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Tyvaso Inhalation System as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter
WSeparation distance according to frequency of transmitter
m150 kHz to 80 MHz
d= 1.2P80 MHz to 800 MHz
d= 1.2P800 MHz to 2.5 GHz
d= 2.3P0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23
D: Glossary
Black Ring: ⮝
A round seal that fits on the bottom of the dome assembly. The seal helps ensure that TYVASO does not mix with the distilled water in the device water chamber.
Inhalation Indicator Lights: ⮝
Two green lights on the top surface of the inhalation device that signals when you should inhale.
On/off, Start/pause (blue) Button: ⮝
A manually activated control on the front of the device that switches between fully on and fully off power states. Once the device power is on, the button begins or pauses treatment.Plugs:Plastic accessories that are inserted into the openings of the dome assembly between treatment sessions. Plugs help keep TYVASO from spilling if the inhalation device tips over.
Power Status Light: ⮝
LED on the back of the device that lights green when power is connected and battery is charging.
Power Port: ⮝
Port on back of device for plugging into a power source using the AC wall plug.
Run / Program Switch: ⮝
A manually activated control on the side of the device that switches between the modes for delivering treatment (Run) and programming breaths (Program).
Sensors: ⮝
The silver objects on the inside wall of the water chamber. The sensors must be covered with distilled water for the TYVASO Inhalation System to function properly.
Volume / Breaths Toggle Button: ⮝
A manually activated control on the side of the device that increases or decreases audio volume (when in Run mode) and programmed breaths (when in Program mode).
Water Chamber: ⮝
The white hollow portion in the center of the inhalation device into which distilled water and the medicine cup are placed.
E: Warranty information Your Tyvaso Inhalation System is granted a full replacement or repair warranty good for 2 years from your date of receipt of the TYVASO Inhalation System Starter Kit or 5 years from the date of manufacture, whichever comes first. This warranty applies to the TYVASO Inhalation System device only. Accessory components are not covered under warranty.
Circumstances That May Void Your Warranty Include: ⮝
Modification or disassembly of the TYVASO Inhalation System device by anyone other than a factory-authorized technician Failure to comply with this written Instructions for Use manual when operating the TYVASO Inhalation System Unapproved use of the TYVASO Inhalation System For all inquiries relating to service or warranty for your TYVASO Inhalation System, contact your specialty pharmacy provider.
You Should Have The Following Information Available: ⮝
Device serial number (located on bottom of TYVASO Inhalation System) Date TYVASO Inhalation System was acquired Nature of the problem and any steps taken to fix it TYVASO
INHALATION SYSTEMTYVASO
(treprostinil)
INHALATION
SOLUTIONTYVASO Inhalation Solution is for prescription use only.
Emergency contact information
United Therapeutics: ⮝
For further questions and information, or to report a problem with your device or an adverse event with your Tyvaso Inhalation System, please call 1-877-UNITHER (1-877-864-8437).