Pari eFlow rapid User manual

nebuliser system
Instructions for use Instrukcja obsługi
Návod k použití Návod na použitie
Οδηγίες χρήσεως Navodila za uporabo
Használati utasítás Kullanım talimatları
Notkunarleiðbeiningar
en pl
cs sk
el sl
hu tr
is

*TouchSpray made under licence from The Technology Partnership plc.
For full details, please read and take note of the instructions for use.
1ASSEMBLE
*
Short guide

For full details, please read and take note of the instructions for use.
2INHALE
Sit in an upright position.
Hold nebuliser handset horizontally.
Short guide

For full details, please read and take note of the instructions for use.
3NEBULISER HANDSET HYGIENE AT HOME
Clean immediately after
inhalation
Warm water, washing up liquid
Disinfect
Disinfect in the steam disinfector for
6 minutes, or boil thoroughly in distilled water
for 5 minutes.
Dry
Allow to air dry (for about 4 hours).
Store in a clean, dry place.
Short guide

eFlow®rapid - 2021-04 1
Instructions for use .........................3
Návod k použití ..............................33
Οδηγιες χρησεως ..........................63
Használati utasítás ........................95
Notkunarleiðbeiningar.................125
Instrukcja obsługi........................155
Návod na použitie........................187
Navodila za uporabo....................217
Kullanım talimatları......................247
en
cs
el
hu
is
pl
sk
sl
tr

2eFlow®rapid - 2021-04

eFlow®rapid - 2021-04 3
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INSTRUCTIONS FOR USE
For eFlow®rapid Type 178G1005
Table of contents
1 IMPORTANT INFORMATION .........................................................5
Organisation of warnings .....................................................................................5
Handling the nebuliser system.............................................................................5
Treatment of babies, children and individuals requiring assistance ...............6
2 PRODUCT DESCRIPTION..............................................................7
Intended purpose...................................................................................................8
Indication................................................................................................................8
Intended use...........................................................................................................8
Contraindications ..................................................................................................8
Intended patient group..........................................................................................9
Life cycle of the medical device ...........................................................................9
3 PREPARING FOR INHALATION..................................................10
Information for the first application ...................................................................10
Preparing the controller ......................................................................................10
Mains power ..........................................................................................................10
Preparing the nebuliser handset........................................................................11
4 PERFORMING INHALATION .......................................................15
Pausing during inhalation...................................................................................15
Display indicators during inhalation..................................................................16
End of the inhalation session.............................................................................16
5 CLEANING AND DISINFECTION .................................................18
Nebuliser handset................................................................................................18
Preparation ............................................................................................................18
Hygienic reprocessing at home .........................................................................18
Cleaning.................................................................................................................18
Disinfection ............................................................................................................19
Hygienic reprocessing in the hospital and doctor’s practice .........................20
Cleaning with thermal disinfection .........................................................................20
Possible alternative: Chemical disinfection............................................................21
en

4eFlow®rapid - 2021-04
Controller, connection cord and power adapter .............................................. 21
Cleaning ................................................................................................................ 21
Disinfection............................................................................................................ 21
Storage................................................................................................................. 21
6 TROUBLESHOOTING ..................................................................22
7 DISPOSAL ....................................................................................26
8 SPARE PARTS AND ACCESSORIES .........................................26
9 TECHNICAL DATA.......................................................................27
General................................................................................................................. 27
eFlow®rapid nebuliser handset ......................................................................... 27
Classification according to EN 60601-1 ............................................................ 28
Materials used ..................................................................................................... 28
Ambient conditions for operation ..................................................................... 29
Ambient conditions for transport and storage................................................. 29
10 SYMBOLS.....................................................................................30
11 TERMS AND CONDITIONS OF WARRANTY..............................31
Service and manufacturer .................................................................................. 31

eFlow®rapid - 2021-04 5
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1IMPORTANT INFORMATION
Read these instructions for use and the
instructions for use of the accompanying
accessories completely before using for
the first time. Keep them safe so that you
can refer to them again later.
Report serious incidents to the manufac-
turer and the competent authorities.
You should have a medical examination
before treating illnesses.
Organisation of warnings
In these instructions for use, safety-
related warnings are organised into
hazard levels:
- The signal word WARNING is used to
indicate dangers that may result in seri-
ous injuries or even death if precaution-
ary measures are not taken.
- The signal word CAUTION is used to
indicate dangers that may result in slight
to moderate injuries or impair treatment
if precautionary measures are not
taken.
- The signal word NOTE is used to indi-
cate general precautionary measures
for working with the product that should
be followed to avoid damaging the
product.
Handling the nebuliser
system
Check the nebuliser system before every
use.
Follow the instructions below in order to
operate the nebuliser system safely:
- Always remove the power adapter from
the socket to ensure that the power is
completely cut off.
- Keep the nebuliser system away from
hot surfaces (e.g., hob).
- Do not allow pets near the cables.
- Do not use the nebuliser system in
areas where there is a risk of explosion
or in the presence of gases that promote
combustion (e.g., oxygen, nitrous oxide,
flammable anaesthetics).
- Do not carry out an inhalation session
while you are driving a motor vehicle
(risk of accident).
CAUTION:
If these instructions for use are not fol-
lowed, injuries and damage to the product
cannot be ruled out.
CAUTION:
Replace all broken, deformed and heavily
discoloured parts. Damaged parts can
impair the function of the nebuliser system
and thus also affect treatment.
WARNING:
Do not operate the nebuliser system if the
power adapter is visibly damaged, since
otherwise there is a danger from contact
with live parts (e.g., electric shock).
WARNING:
Never remove the power adapter from
the socket with wet hands. There may
be a danger of electric shock.

6eFlow®rapid - 2021-04
Treatment of babies, children
and individuals requiring
assistance
WARNING:
Children and anyone who requires assis-
tance must be supervised constantly by
an adult during inhalation therapy. This is
the only way to ensure safe and effective
treatment. These individuals often under-
estimate the hazards associated with the
equipment (e.g., risk of strangulation with
the cable), and this can result in risk of
injury.
WARNING:
The product contains small parts. Small
parts can block the airways and pose
a choking hazard. Therefore, be sure to
keep them out of the reach of children at
all times.

eFlow®rapid - 2021-04 7
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2PRODUCT DESCRIPTION
Check that all components are contained
in your package. If they are not, contact
your local service partner (see "Service
and manufacturer", page 31).
9
9a
3
6
7
5
2
8
1
5a
4
1a
1eBase®Controller
1a ON/OFF button
2Two eFlow®rapid nebuliser handsets
(incl. aerosol head)
3eFlow®rapid Aerosol Head
4Medication cap
5Medication reservoir and
5a Aerosol chamber (preassembled)
6Inspiratory valve
7Mouthpiece with expiratory valve
8Connection cord (connection between
the controller and the nebuliser
handset)
9Power adapter
9a Country-specific adapter
(AU, EU, UK, US)
- Carrying case and nebuliser handset
bag
-easycare cleaning aid for aerosol
heads

8eFlow®rapid - 2021-04
Intended purpose
The eFlow®rapid nebuliser system is
intended to administer nebuliser solutions
or suspensions as an aerosol for
inhalation.
Indication
The eFlow®rapid nebuliser system is
indicated to administer nebuliser solutions
or suspensions approved for the treatment
of diseases of the lower airways.
Intended use
The nebuliser system must only be used
in accordance with its intended purpose.
The frequency of inhalation sessions may
vary depending on the nebuliser solutions
or suspensions and the clinical picture.
Take note of any limitations in the pack-
age leaflet accompanying the respective
nebuliser solutions or suspensions.
For reasons of hygiene and to avoid
cross-infections, the eFlow®rapid nebu-
liser handset and the connection cord
must only be used by one patient. For
patients at greater risk from infection, e.g.,
with cystic fibrosis (CF) or a weakened
immune system, or for those infected with
MRSA it is recommended that the
eBase®Controller and the power adapter
are also used by only one patient.
Only original PARI accessories must be
used to operate the system (see "SPARE
PARTS AND ACCESSORIES", page 26).
PARI Pharma GmbH is not responsible
for damage if the system is used
improperly or contrary to the instructions.
Contraindications
For the eFlow®rapid nebuliser system no
contraindication is known to
PARI Pharma GmbH. Take note of con-
traindications of the medicine in the
accompanying package leaflet.
Info:
The eBase®Controller can also be
used for a medication-specific nebu-
liser handset (Tolero®, Zirela® and
Altera®). Follow the instructions for
use of the nebuliser handset as well.
CAUTION:
Medications that are approved for inhala-
tion with a medication-specific nebuliser
handset must not be used with an
eFlow®rapid nebuliser handset (risk of
incorrect dosage).
CAUTION:
Never attempt to inhale essential oils, as
this can cause irritation of the airways
(intense coughing).
CAUTION:
Using accessories and spare parts other
than those supplied by the manufacturer
may cause increased electromagnetic
emissions or reduced electromagnetic
immunity, leading to a malfunction.

eFlow®rapid - 2021-04 9
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Intended patient group
The eFlow®rapid nebuliser system is suit-
able for use by all age groups. Inhalation
with the mouthpiece is the most effective
form of inhalation, since it results in mini-
mum medication losses on the way to the
lung. For babies and infants who cannot
use the mouthpiece to inhale, PARI offers
appropriate masks as accessories.
The nebuliser system is only suitable for
use by patients who can breathe unas-
sisted and are conscious.
The nebuliser handsets are not suitable
for use by patients who are receiving
mechanical ventilation or have undergone
a tracheotomy.
Life cycle of the medical
device
The nebuliser handset with aerosol head
is designed for multiple uses. For optimal
inhalation therapy with exact dosing and
short inhalation time and to ensure the
best possible hygiene conditions, nebu-
liser handsets and aerosol heads must be
replaced regularly.
The life cycle of the nebuliser handset
depends on the daily number and duration
of the inhalation cycles performed, the
composition and variety of the nebuliser
solutions used, and the cleaning/hygiene
processes applied.
Over time, medication residues and
microparticles introduced from the envi-
ronment can partially block the fine pores
in the aerosol head and prolong the nebu-
lisation time. When the cleaning instruc-
tions are followed regularly and the
easycare cleaning aid is used, the aerosol
head has a possible life cycle between
three and six months. If the nebuliser
handset is used frequently (two or more
different nebuliser solutions several times
a day), the recommended useful life of the
aerosol head may be shortened to
a period of one to three months due to sig-
nificantly longer nebulisation time.
It is recommended to replace the plastic
parts (nebuliser handset without aerosol
head) after 12 months at the latest.
For medication-specific nebuliser hand-
sets (Tolero®, Zirela®and Altera®) and for
the eFlow®rapid nebuliser handset for
inhalation of antibiotics, replacement after
one month is recommended.
The expected life cycle of the eBase®
Controller is 3 years.

10 eFlow®rapid - 2021-04
3PREPARING FOR INHALATION
Information for the first
application
- Wash your hands thoroughly every time
before using the nebuliser system.
- To avoid irritation of the airways due to
inhaling aerosol when it is too cold and
impairment of the aerosol properties, do
not use medications straight from the
refrigerator.
- Clean the nebuliser handset and aero-
sol head before the first application (see
"CLEANING AND DISINFECTION",
page 18).
Preparing the controller
The controller can be operated with the
delivered batteries or with commercially
available rechargeable batteries.
• Open the battery compartment by lifting
the clip.
• Insert the batteries as indicated by the
polarity symbols.
• Close the battery compartment. The
controller is ready for use when the bat-
teries have been inserted.
Mains power
Check that the power adapter is intact
before every application.
The eBase®Controller was developed for
mobile use. Therefore, insert batteries
before use and leave them in the control-
ler during mains operation. This guaran-
tees smooth functionality. This does not
deplete the energy reserves of the
batteries.
Info:
Rechargeable batteries cannot be
recharged in the controller!
WARNING:
Do not use a power adapter that is
damaged or faulty.

eFlow®rapid - 2021-04 11
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• Replace the country-specific adapters
for the power adapter as required. To
unlock, press the clip and push the
country-specific adapter upwards.
When plugging in, make sure that the
adapter (9a) engages in the power
adapter housing.
• Connect the power adapter to the power
cord socket on the controller.
When the power adapter is plugged into
a socket, the controller is ready for use.
Preparing the nebuliser
handset
• Open the aerosol chamber (5a).
9a
CAUTION:
Check the parts of your nebuliser handset
before every use. Replace all broken,
deformed and heavily discoloured parts.
Damaged parts and incorrectly assem-
bled nebuliser handsets can impair the
function of the nebuliser handset and thus
also affect the treatment.
Info:
The medication reservoir and aerosol
chamber are already preassembled
and must not be detached from one
another.
5a

12 eFlow®rapid - 2021-04
• Insert the aerosol head (3) into the
openings on the medication reservoir.
It must snap noticeably into place.
• Insert the inspiratory valve (6) in the
aerosol chamber.
When doing so, check that the two valve
flaps are seated correctly.
They must lie perfectly flush and face
towards the aerosol chamber following
insertion.
• Close the aerosol chamber.
• Attach the mouthpiece (7) to the aerosol
chamber.
NOTE:
Do not touch the membrane (the curved
metal surface in the middle of the aerosol
head) to avoid damage.
60
3
NOTE:
If the snap closure does not close,
ensure that the inspiratory valve is
seated correctly. It must lie flat against
the aerosol chamber.
Info:
For inhalation with a mask, follow the
instructions for use of the mask you
are using.
6
7

eFlow®rapid - 2021-04 13
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• Connect the connection cord (8) to the
nebuliser handset.
• Connect the connection cord (8) to the
controller.
• Place the nebuliser handset on a firm,
flat surface.
• Add the dosing of medication prescribed
by your doctor to the medication reser-
voir.
• Close the medication reservoir.
8
8
WARNING:
Ensure that the medication is filled no
higher than the upper scale graduation
mark (6 ml). Do not overfill under any
circumstances!
Info:
If you intend to inhale several medica-
tions one after the other, rinse all
nebuliser handset parts thoroughly
with warm tap water before refilling.

14 eFlow®rapid - 2021-04
• Check that all parts are connected
tightly and that the medication reservoir
is sealed.

eFlow®rapid - 2021-04 15
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4PERFORMING INHALATION
• Sit in an upright position and relax. This
makes inhaling easier and improves
uptake of the medication in the airways.
• Hold the nebuliser handset in your
hand.
• Hold the mouthpiece between your
teeth and enclose with your lips. The
lips must not touch the blue expiratory
valve.
• Press the ON/OFF button on the con-
troller to start the inhalation session.
A green LED next to the ON/OFF button
lights up and an audible signal (1 beep) is
emitted to indicate readiness for use.
• Inhale and exhale slowly and deeply
through the mouthpiece. Hold the
mouthpiece in your mouth while breath-
ing out as well.
Do not breathe through your nose. You
can use a nose clip if necessary.
Pausing during inhalation
If it is necessary to interrupt the inhalation
session briefly, activate Pause mode:
• Press the ON/OFF button for approx.
1 second.
Pause mode is activated when the LED
flashes green.
• Press the ON/OFF button for approx.
1 second again to resume the inhalation
session.
If pausing for a longer time, switch the
controller off by pressing the ON/OFF but-
ton for approx. 2 seconds.
As long as there is enough liquid in the
medication reservoir, nebulising can be
restarted by pressing the ON/OFF button
again.
CAUTION:
Hold the nebuliser handset horizontally
all the time while performing the inhala-
tion. If the handset is tilted, errors in the
dosage may occur.
Info:
It is normal for aerosol to escape
through the expiratory valve in the
mouthpiece during exhalation; this
is not a malfunction.
Info:
Pause mode can only be activated
after an operating time of a few
seconds.

16 eFlow®rapid - 2021-04
Display indicators during
inhalation
The following display indicators appear
during the inhalation session:
End of the inhalation session
The inhalation session is finished as soon
as no more aerosol is generated, and the
following display indicator appears:
The controller switches off automatically.
If the controller switches itself off consider-
ably sooner or later than usual, follow the
instructions in Chapter "TROUBLE-
SHOOTING", page 22.
Start
During
inhalation
Pause mode
activated
Nebulising with battery power
Nebulising with mains power
Pause mode when operating
with batteries
Pause mode when operating
with mains power
Info:
Note that about 1 ml of medication
cannot be nebulised and remains
unused in the medication reservoir of
the eFlow®rapid nebuliser handset;
this residue must be discarded. This
is necessary to ensure a safe dosing
of medication is delivered and does
not constitute a malfunction.
approx. 1 ml