TYVASO TD-100 User manual
TYVASOTYVASO INHALATION SYSTEM
Instructions for use
INHALATION SYSTEM
TYVASO
Instructions for Use
treprostinil
INHALATION
SOLUTION
™
TYVASOTYVASO INHALATION SYSTEM
INSTRUCTIONS FOR USE
treprostinil
INHALATION
SOLUTION
™
®
TYVASOTYVASO
(treprostinil)
INHALATION
SOLUTION
PROSTACYCLIN MADE PRACTICAL
®
®
TYVASO Inhalation Solution is for prescription use only.
TYVASO is a registered trademark of United Therapeutics Corporation.
Literature issued August, 2014
For further questions and information, or to report
an adverse reaction, please call 1-877-UNITHER (1-877-864-8437).
Distributed by:
United Therapeutics Corporation
Research Triangle Park, North Carolina 27709
© 2014, United Therapeutics Corporation. All rights reserved.
RTP 3098A Rev. 00
TYVASOTYVASO
(treprostinil)
INHALATION
SOLUTION
PROSTACYCLIN MADE PRACTICAL
®
TYVASOTYVASO INHALATION SYSTEM
Instructions for use
INHALATION SYSTEM
TYVASO
Instructions for Use
treprostinil
INHALATION
SOLUTION
™
TYVASOTYVASO INHALATION SYSTEM
INSTRUCTIONS FOR USE
treprostinil
INHALATION
SOLUTION
™
®
Emergency contact information
Clinician:
Nurse educator:
Specialty pharmacist:
United Therapeutics:
4
The device is equipped with a multifunctional status light and a
separate control light for inhalation.
Control light for inhalation
Green light on - Inhale
Green light o - Exhale, then breathe normally
Status light
Yellow - ready for operation
Green - device in operation
Red - device error indication
Device Display Messages
Displays the number of breaths in an active cycle.
(PA) Pause - Displayed if user pauses a treatment session.
(En) End - Displayed when a treatment session is complete.
(LH) Low Hydrogen (ie, Low Water) - Displayed if device
detects wrong or missing contact fluid in chamber.
(LB) Low Battery - Displayed if device battery does not have
enough power to start a treatment.
Inhalation device
“ON/OFF” Button -
Switches between
fully on and fully o
power states.
“START/STOP”
Treatment Button -
Begins or pauses
treatment.
Markings, Indicators, and Symbols
Graphics in IFU are for representation only. Images may not be shown to scale
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.
5
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.
Device markings
TYVASOTYVASO INHALATION SYSTEM
Instructions for use
INHALATION SYSTEM
TYVASO
Instructions for Use
treprostinil
INHALATION
SOLUTION
™
TYVASOTYVASO INHALATION SYSTEM
INSTRUCTIONS FOR USE
treprostinil
INHALATION
SOLUTION
™
®
TYVASOTYVASO
(treprostinil)
INHALATION
SOLUTION
PROSTACYCLIN MADE PRACTICAL
®
®
TYVASO Inhalation Solution is for prescription use only.
TYVASO is a registered trademark of United Therapeutics Corporation.
Literature issued August, 2014
For further questions and information, or to report
an adverse reaction, please call 1-877-UNITHER (1-877-864-8437).
Distributed by:
United Therapeutics Corporation
Research Triangle Park, North Carolina 27709
© 2014, United Therapeutics Corporation. All rights reserved.
RTP 3098A Rev. 00
TYVASOTYVASO
(treprostinil)
INHALATION
SOLUTION
PROSTACYCLIN MADE PRACTICAL
®
TYVASOTYVASO INHALATION SYSTEM
Instructions for use
INHALATION SYSTEM
TYVASO
Instructions for Use
treprostinil
INHALATION
SOLUTION
™
TYVASOTYVASO INHALATION SYSTEM
INSTRUCTIONS FOR USE
treprostinil
INHALATION
SOLUTION
™
®
Emergency contact information
Clinician:
Nurse educator:
Specialty pharmacist:
United Therapeutics:
4
The device is equipped with a multifunctional status light and a
separate control light for inhalation.
Control light for inhalation
Green light on - Inhale
Green light o - Exhale, then breathe normally
Status light
Yellow - ready for operation
Green - device in operation
Red - device error indication
Device Display Messages
Displays the number of breaths in an active cycle.
(PA) Pause - Displayed if user pauses a treatment session.
(En) End - Displayed when a treatment session is complete.
(LH) Low Hydrogen (ie, Low Water) - Displayed if device
detects wrong or missing contact fluid in chamber.
(LB) Low Battery - Displayed if device battery does not have
enough power to start a treatment.
Inhalation device
“ON/OFF” Button -
Switches between
fully on and fully o
power states.
“START/STOP”
Treatment Button -
Begins or pauses
treatment.
Markings, Indicators, and Symbols
Graphics in IFU are for representation only. Images may not be shown to scale
5. Accessories
Medicine cups* Dome assembly
with bae plate inside*
Inhalation piece* Mouthpiece* Two (2) Filter shells*
Filter membranes
(use two (2) per day)*
Plugs* Carrying case Distilled water carrier
(optional)
Treatment Tracker*
Note: Supplies are not shown to scale.
*These accessories are replaced every month. Replacement accessories are included in the Monthly Refill Kit.
7
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
4. One of the provided power sources
Use only distilled water to
fill your inhalation device
once per day.
AC wall plug (2) Rechargeable
battery
12V DC
adapter
6
Use one (1) ampule per day.
Gently hold the ampule in the upright (top-
up) position and twist o its top.
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.
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.
Squeeze ampule using
thumb and finger
345
Foil pouch
Ampule
Remove top
Twist
9
CAUTION
Ampules must be used within seven
(7) days of opening foil pouch.
Open only (1) pouch at a time. Discard
any unused ampules after seven (7)
days.
CAUTION
If any medicine from the ampule spills
on your hands, wash your hands
immediately.
Medicine contact with the skin can
cause irritation.
Medicine cup
Bottom tip of cup
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.
ONLY USE DISTILLED WATER in 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.
Before using the TYVASO Inhalation System,
you should:
• Wash your hands
• Make sure the device is NOT
connected to a power source
• Make sure the device is resting on
a stable, flat surface during assembly
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.
12
45 mL
distilled water
Chamber
Sensor
(inside chamber)
Setting Up Your TYVASO Inhalation System
Filling the Inhalation Device Chamber and Medicine Cup
Target level
8
Blue ring CAUTION
Make sure you insert only one (1)
medicine cup. Inserting multiple
cups will prevent the flow of
medicine.
Insert the mouthpiece into the
inhalation piece.
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.
Inhalation piece
Inhalation piece
Mouthpiece
34
Filter shell port
Close
Filter
Filter shell
Open
5
11
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.
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.
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.
12
Assembling the Inhalation Device
Dome assembly Filter shell port
IMPORTANT
The dome assembly “clicks” only the
first time it connects to the medicine
cup. If you then realign the dome
assembly you will not hear another
click.
Visually check to make sure the blue plastic
bae 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 bae plate
is loose or disconnected, use a new dome
assembly. If you need to order a new dome
assembly, contact your specialty pharmacy
provider.
Bae plate
SIDE VIEW
Black ring
Alignment
circles
10
AC wall plug
(plugs into standard
wall outlet)
Rechargeable
Battery
(ensure fully
charged) 12V DC adapter
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.
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 o.
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.
Turning On the Inhalation Device
21
Inhalation
indicator light
Press
ON
Status light
(yellow)
13
Filter shell Filter shell
Assembling the Inhalation Device (continued)
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.
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.
67
Display screen
Mouthpiece
Inhalation
indicator light
Status light
12
Make sure the device is powered o. To power o the device,
press and hold the ON/OFF button for three (3) seconds. When you
hear a short beep and the display screen turns o, release the ON/
OFF button.
To set the number of breaths, press and hold both the START/STOP
and ON/OFF buttons at the same time until 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.
1
14
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.
(example of Treatment Tracker)
TIME:
DATE:
BREATHS
I’m taking ______ breaths per treatment session.
1
1 2 3 4 5 6 7 8 9
TIME:
2
TIME:
3
TIME:
4
8:15 am
6
Monday
1 9 2012
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.
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.
2 3
Decrease number
of breaths
Increase number
of breaths
+
_
15
16
Before inhaling your medicine, check the number on the
display screen to make sure it matches the prescribed
number of breaths for that treatment session. Record this
value in your Treatment Tracker.
If the number of breaths on the display does not match
the number of breaths in your prescription go to page 14
“Setting the Number of Breaths in a Treatment Session”
and repeat steps 1-3.
IMPORTANT
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.
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.
Inhaling Your Medicine, TYVASO®(treprostinil) Inhalation Solution
Track
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.
1
Lights
Display
screen
17
Inhaling Your Medicine, TYVASO®(treprostinil) Inhalation Solution (continued)
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.
Press Wait
Beep...Beep Beeeeeep Beep
Flashing light
Exhale Inhale
Perform steps A-G to complete one (1) treatment session.
Follow the instructions exactly to make sure you receive the correct medication dose.
2
18
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 o 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
o automatically.
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.
PressTrack
3
19
CAUTION
If medicine does not appear to be flowing properly, the system might be set
up incorrectly. See Troubleshooting section, pages 30-35, for details.
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 to Cleaning 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.
Disconnect the device from its power source.
1
20
Storing the TYVASO Inhalation System Between Treatment Sessions
Remove the mouthpiece.
2 3
Filter shell
Remove both filter shells.
Do NOT remove the filter membranes from filter shells until after the
last treatment session of the day.
Filter shell
Mouthpiece
21
IMPORTANT
When removing accessories between treatment sessions,
hold the device by its base to avoid spilling the medicine.
Storing the TYVASO Inhalation System Between Treatment Sessions (continued)
Leave the dome assembly and medicine cup (with the medicine
still in it) connected to the device.
5
Dome assembly
Medicine cup
Remove the inhalation piece.
4
Inhalation piece
22
Insert a plug into each of the open holes on the dome assembly to
prevent the medicine from spilling out.
The inhalation device with the plugged dome assembly and all the
accessories can be stored in the carrying case between treatment
sessions.
6 7
Plugs
Carrying case
23
IMPORTANT
IMPORTANT
If the plugs are not in place, the medicine may spill. If you
spill any medicine, start over with a new ampule.
Store the inhalation device in an upright position until the next
treatment session. See page 36 for additional storage and transport
information.
Open the filter shells by twisting in
opposite directions.
Remove and discard the used filter
membranes.
Remove both filter shells.
Cleaning and Maintenance of the TYVASO Inhalation System
End of Day Cleaning of the Accessories
Filter shell Filter shell
Disconnect the device from the power source.
1 2 3
Open
Filter
membrane
24
Dome assembly
Medicine cup
Remove the dome assembly by turning it
counter-clockwise (to the left). The medicine cup
should stay attached to the dome assembly.
Remove the inhalation piece.Remove the mouthpiece.
4 5 6
Inhalation piece
Mouthpiece
CAUTION
If any medicine from the medicine cup spills on
your hands, wash your hands immediately.
Medicine contact with the skin can cause
irritation.
25
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.
Clean the accessories (pictured below) by hand in mild, soapy, warm
water, then rinse them thoroughly with water. Allow accessories to air
dry.
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.
End of Day Cleaning of the Accessories (continued)
7 8
9
Dome assembly
Medicine cup
Squeeze
Squeeze
26
Discard the remaining TYVASO®(treprostinil) Inhalation
Solution in an appropriate waste receptacle. Throw away
the plastic medicine cup. Do not reuse the medicine cup.
Do not recycle the medicine cup.
Mouthpiece
Dome assembly Filter shells
Inhalation piece
Do not place the inhalation device in water or in a
dishwasher.
Do not place the inhalation device or its accessories in a
microwave or conventional oven.
IMPORTANT IMPORTANT
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.
Carrying case
10
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 dicult 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.
27
IMPORTANT
All service of the TYVASO Inhalation System must be
performed by the manufacturer. Attempting to alter the device
in any way voids the warranty and may cause a malfunction.
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. Do NOT use 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.
Charging Your TYVASO Inhalation System
Rechargeable Battery
Press and hold
Battery charge
indicator light
28
A new battery might not be fully charged when you
receive it. Always charge a new battery before you first
use it.
IMPORTANT
•
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.
29
Make sure the battery is not connected to the inhalation device
while the battery is charging. The battery will charge more
slowly and require a longer time to fully charge if plugged into
the inhalation device.
IMPORTANT
Troubleshooting the TYVASO Inhalation System
Low battery (LB)
Problem Possible causes Corrective actions
30
• Low battery
• Defective adapter (AC wall plug or 12V DC
adapter)
• AC wall plug is still plugged into battery and
battery is connected to device.
•
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.
• Ensure that the plug is properly connected
to an outlet.
• Turn o 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.
31
Low hydrogen (LH)
Problem Possible causes Corrective actions
Too low
• Device chamber is empty or distilled water level
in the device chamber is too low.
• The distilled water you are using is too purified
• The sensor has a thin layer of build-up
• 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).
• 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.
• 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 TYVASO® (treprostinil) Inhalation Solution in
the medicine cup
• Damaged medicine cup
• Distilled water level in the device chamber is
too high
• Multiple medicine cups attached to the dome
assembly
No medicine comes out of the device
during a treatment session
• Unplug the device from its power source. Fill
medicine cup with one (1) ampule of TYVASO.
• Unplug the device from its power source.
Replace the medicine cup.
• Unplug the device from its power source.
Empty the device chamber then refill it with
45 mL of distilled water.
• 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.
Too high
Troubleshooting the TYVASO Inhalation System (continued)
Problem Possible causes Corrective actions
Two (2)
medicine cups
32
Problem Possible causes Corrective actions
• Filter membrane is clogged
Dicult to breathe in medicine
through the mouthpiece
• Unplug the device from its power source. Replace filter
membrane (see page 11).
Open Filter
membrane
33
No “click” was heard when
attaching the dome assembly
• No medicine cup in the chamber of the device
• Multiple medicine cups attached to the dome
assembly
• Dome assembly is not securely in place
• Insert an empty medicine cup into the
chamber of the device and fill it with one (1)
ampule of TYVASO.
• 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.
• 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.
Troubleshooting the TYVASO Inhalation System (continued)
Problem
34
Possible causes Corrective actions
Two (2)
medicine cups
Problem Possible causes Corrective actions
• Device is disconnected from its power source
• Power source is temporarily disrupted (for
example, electricity interruption due to a
storm)
Loss of power during treatment
• 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.
• 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.
35
Specifications
Model TD-100/A
Size 98 x 66 x 105 mm
Weight, inhalation device 280 g (9.9 ounces)
Types of power supply AC wall plug
12V DC adapter
Rechargeable battery
Power 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 40ºC/20-80% relative humidity
Operating temperature/humidity 15 to 25ºC/40-75% relative humidity
Inhalation Device
36
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 bae plate
ON-104/C Inhalation piece
ON-105/C Mouthpiece
TD-118 Water level cup
TD-153 Carrying case
TD-155 Distilled water carrier
Accessories
37
*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.
Patient Starter Kit (PSK) 12.2” x 14.3” x 16.0”
Monthly Refill Kit (MRK) 9.9” x 6.1” x 16.1”
Institutional Starter Kit (ISK) 12.2” x 14.3” x 16.0”
Mass Median Aerosol Diameter (MMAD)* mean = 2.0 µm
SD = 0.3
Total Emitted Dose per Breath** mean = 6.0 µg
SD = 0.4
Total Aerosol Mass* mean = 58 µg
SD = 5.9
Total Respirable Dose* mean = 44.6 µg
SD = 3.5
Respirable Fraction* mean = 73%
SD = 5%
Geometric Standard Deviation (GSD)* mean = 2.6 µm
SD = 0.4
Packaging Dimensions (Approximate Length x Width x Height)
TYVASO Mass and Particle Specifications for 9 breaths
Note: Part number subject to change.
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.
Bae plate: A blue plastic piece that is inside the dome
assembly. The bae plate helps turn TYVASO into particles that
are the correct size to inhale.
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 chamber.
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
bae 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.
38
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 o 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.
Water chamber: The white hollow portion in the center of the
inhalation device into which distilled water and the medicine cup
are placed.
39
This manual suits for next models
1
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