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
Table of Contents
2
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.
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.
Introduction
3
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 (see
Specifications on page 36).
IMPORTANT
• Do not start treatment with TYVASO until you have been
trained to use the TYVASO Inhalation System. Make sure you
understand all of the directions. Always ask your doctor or
specialty pharmacy provider if you have any questions or are
unsure of anything you are taught.
• TYVASO is for use only with the TYVASO Inhalation System.
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
Table of Contents
2
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.
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.
Introduction
3
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 (see
Specifications on page 36).
IMPORTANT
• Do not start treatment with TYVASO until you have been
trained to use the TYVASO Inhalation System. Make sure you
understand all of the directions. Always ask your doctor or
specialty pharmacy provider if you have any questions or are
unsure of anything you are taught.
• TYVASO is for use only with the TYVASO Inhalation System.
