Pari eFlow rapid User manual

nebuliser system
Instructions for use Használati utasítás
   Notkunarleiðbeiningar
Návod k použití Instrukcja obsugi
  Návod na použitie
Kasutusjuhend Navodila za uporabo
Upute za uporabu Kullanım talimatları
en hu
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cs pl
el sk
et sl
hr tr
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*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
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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
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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
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eFlow®rapid - 2022-07 1
Instructions for use .........................3
Инструкции за употреба .............33
Návod k použití ..............................65
Οδηγιες χρησεως ..........................95
Kasutusjuhend.............................127
Upute za uporabu ........................157
Használati utasítás ......................187
Notkunarleiðbeiningar.................217
Instrukcja obsługi........................247
Návod na použitie........................279
Navodila za uporabo....................309
Kullanım talimatları......................339
en
bg
cs
el
et
hr
hu
is
pl
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tr
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2eFlow®rapid - 2022-07
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eFlow®rapid - 2022-07 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
Lifetime of the medical device..............................................................................9
3 PREPARING FOR INHALATION..................................................10
Information for the first application ...................................................................10
Preparing the controller ......................................................................................10
Operation with the power adapter..........................................................................10
Preparing the nebuliser handset........................................................................11
4 PERFORMING INHALATION .......................................................14
Pausing during inhalation...................................................................................14
Screens during inhalation...................................................................................15
End of the inhalation session.............................................................................15
5 CLEANING AND DISINFECTION .................................................17
Nebuliser handset................................................................................................17
Preparation ............................................................................................................17
Hygienic reprocessing at home .........................................................................18
Cleaning.................................................................................................................18
Disinfection ............................................................................................................19
Hygienic reprocessing in the hospital and doctor’s practice .........................20
Cleaning with thermal disinfection .........................................................................20
en
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4eFlow®rapid - 2022-07
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..............................32
Service and manufacturer .................................................................................. 32
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eFlow®rapid - 2022-07 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 authority.
You should have a medical examination
before beginning treatment for an illness.
Organisation of warnings
In these instructions for use, safety-
related warnings are organised according
to the degrees of hazard:
- The signal word WARNING is used to
indicate dangers that may result in
serious injuries or even death if precau-
tionary 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
indicate general precautionary meas-
ures for handling the product that should
be followed to avoid damaging the
product.
Handling the nebuliser
system
Check the nebuliser system before each
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 carry out an inhalation session
while you are driving a motor vehicle
(risk of accident).
WARNING:
If these instructions for use are not
followed, 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 risk of contact with live
parts (e.g., electric shock).
WARNING:
Never remove the power adapter from
the socket with wet hands. There may
be a risk of electric shock.
WARNING:
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).
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6eFlow®rapid - 2022-07
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 reach of children at all
times.
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eFlow®rapid - 2022-07 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 32).
9
9a
4
5
7
6
2
8
1
6a
3
1a
1eBase®Controller
1a ON/OFF button
2Two eFlow®rapid nebuliser handsets
(incl. aerosol head)
3Medication cap
4Aerosol head
eFlow®rapid Aerosol Head
5Inspiratory valve
6Medication reservoir and
6a Aerosol chamber (preassembled)
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
- Batteries (optional)
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8eFlow®rapid - 2022-07
Intended purpose
The eFlow®rapid nebuliser system is
intended to administer solutions or
suspensions for a nebuliser handset as
an aerosol for inhalation.
Indication
The eFlow®rapid nebuliser system is
intended to administer solutions or
suspensions for a nebuliser handset
which are 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 solution
or suspension used for a nebuliser hand-
set and the clinical picture. Take note of
any limitations in the package leaflet
accompanying the respective solution or
suspension for a nebuliser handset.
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 improp-
erly or contrary to the instructions.
Contraindications
For the eFlow®rapid nebuliser system no
contraindication is known to
PARI Pharma GmbH. Take note of
contraindications of the medicine in the
accompanying package leaflet.
WARNING:
For reasons of hygiene and to avoid
cross-infections, the eFlow®rapid
nebuliser handset and the connection
cord must be used by one patient only.
For patients at greater risk of infection,
e.g., with cystic fibrosis (CF) or a weak-
ened immune system, or for those
infected with MRSA it is recommended
that the eBase®Controller and the power
adapter are also used by one patient only.
Info:
The eBase®Controller can also be
used for a drug-specific nebuliser
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 drug-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.
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eFlow®rapid - 2022-07 9
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Intended patient group
The eFlow®rapid nebuliser system is
suitable for use by all age groups. Inhala-
tion with the mouthpiece is the most effec-
tive form of inhalation, since it results in
minimum medication losses on the way to
the lung. For babies and toddlers 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
unassisted and are conscious.
The nebuliser handsets are not suitable
for use by patients who are receiving
mechanical ventilation or have undergone
a tracheotomy.
Lifetime 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,
nebuliser handsets and aerosol heads
must be replaced regularly.
The lifetime 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
environment can partially block the fine
pores in the aerosol head and prolong the
nebulisation times. When the cleaning
instructions and followed regularly and the
easycare cleaning aid is used, the aerosol
head has a possible lifetime of 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
significantly longer nebulisation times.
It is recommended that the plastic parts
(nebuliser handset without aerosol head)
be replaced after 12 months at the latest.
For drug-specific nebuliser handsets
(Tolero®, Zirela®and Altera®) and for the
eFlow®rapid nebuliser handset for inhala-
tion of antibiotics, replacement after one
month is recommended.
The expected lifetime of the
eBase®Controller is 3 years.
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10 eFlow®rapid - 2022-07
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.
Preparing the controller
The controller can be operated with
batteries or with rechargeable batteries.
• Open the battery compartment by lifting
the clip.
• Insert the batteries as indicated by the
polarity symbols.
• Close the battery compartment.
Operation with the power adapter
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
controller during mains operation. This
guarantees smooth functionality. This
does not deplete the energy reserves of
the batteries.
WARNING:
Clean the nebuliser handset and
aerosol head before the first application
(see “CLEANING AND DISINFEC-
TION”, page 17).
Info:
Rechargeable batteries cannot be
recharged in the controller!
WARNING:
Do not use a power adapter that is
damaged or faulty.
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eFlow®rapid - 2022-07 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.
• Plug the power adapter into an electrical
wall socket.
Preparing the nebuliser
handset
• Insert the aerosol head (4) into
the openings on the medication
reservoir (6) (opened aerosol
chamber (6a)).
It must snap noticeably into place.
9a
CAUTION:
Check the parts of your nebuliser handset
before each 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.
CAUTION:
Do not touch the membrane (the curved
metal surface in the middle of the aerosol
head) to avoid damage.
60
4
6a
6
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12 eFlow®rapid - 2022-07
• Insert the inspiratory valve (5) 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.
• Connect the connection cord (8) to the
nebuliser handset.
NOTE:
If the snap closure does not close,
ensure that the inspiratory valve is
seated correctly. It must lie flat against
the aerosol chamber.
5
Info:
For inhalation with a mask, follow the
instructions for use of the mask you
are using.
7
8
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eFlow®rapid - 2022-07 13
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• Connect the connection cord (8) to the
controller.
• Place the nebuliser handset on a firm,
flat surface.
• Add the quantity of medication
prescribed by your doctor to the
medication reservoir.
• Close the medication reservoir.
• Check that all parts are connected
tightly and that the medication reservoir
is sealed.
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.
8
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14 eFlow®rapid - 2022-07
4PERFORMING INHALATION
• Sit in an upright position and relax. This
makes inhalation 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
controller 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
breathing 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 button for approx. 2 seconds.
As long as there is enough liquid in the
medication reservoir, nebulisation can be
restarted by pressing the ON/OFF button
again.
CAUTION:
Hold the nebuliser handset horizontally
at all times while performing the inhala-
tion. If the handset is tilted, this may
result in the incorrect dosage being
delivered.
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.
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eFlow®rapid - 2022-07 15
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Screens during inhalation
The following screens 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 screen 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
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16 eFlow®rapid - 2022-07
For safe disposal of the leftover medica-
tion, follow the information in the
medication package leaflet.
• When operating with the power adapter:
When the inhalation session has ended,
disconnect the power adapter plug from
the socket.
• Carry out the hygiene procedures
(see “CLEANING AND DISINFEC-
TION”, page 17) immediately after the
inhalation session has ended.
Info:
The nebulisation times may gradually
become longer with increasing length
of use. This does not constitute a
malfunction of the nebuliser handset.
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