Vectura Akita JET User manual

AKITA®JET Inhalation System Instructions for Use
WARNING:Before using your AKITA JET Inhalation System, read and understand the entire Instructions
for Use. Save these Instructions for Use for future reference.
Patents:
EP 983103; US 6606989 / EP 1136093; DE 10013093 / US 7077125; CA 2386442
Additional Patents Pending
Manufacturer:
Vectura Group plc.
One Prospect West - Chippenham,
Wiltshire, SN14 6FH – United Kingdom
Email: [e-mail]
Item Code 01DK0101 (DAW-00025 rev. 05)
Vectura Ireland Limited
The Brickhouse
Block 1, Clanwilliam Court
Lower Mount Street
Dublin, D02 CF97
Ireland
0123

AKITA® JET
2
Contents
1Introduction 4
1.1 Intended Use 4
1.2 Liability 4
2Important Information for Your Safety 6
3Getting Started 8
4Assembling AKITA JET Inhalation System 9
4.1 Connection of Power Supply and Power Cord 9
4.2 Inserting Smart Card 9
4.3 Nebuliser Assembly 10
4.4 Installing Nebuliser Holder 10
5Cleaning and Disinfecting AKITA JET Inhalation System 12
5.1 Immediately after Use 12
5.2 Cleaning 12
5.3 Disinfection 13
5.4 Storage, Transporting 14
5.5 Cleaning AKITA JET Control Unit 14
5.6 Replacing Filter 14
6Taking Treatment 16
6.1 Filling the Nebuliser 16
6.2 Connecting Tubes to the Nebuliser 16
6.3 Connecting Tubes to the Control Unit 17
6.4 Switching on AKITA JET Inhalation System 18
6.5 Setting Inhalation Time (per breath) 19
6.6 Medication Selection 19
6.7 Inhalation 20
7Additional Requirements for Multi Patient Use 23
7.1 Precautions When Inhaling 23
7.2 Immediately After Use 23
7.3 Cleaning / Disinfect the Nebuliser 24
7.4 Sterilisation of the Nebuliser 25

3
8Smart Card 26
8.1 Important Instructions for the Smart Card 26
8.2 Medication-Specific Smart Cards 27
9Troubleshooting 29
10 Warranty 31
11 Technical Data 32
11.1 General 32
11.2 Aerosol Characteristics 32
11.3 Operating Conditions 33
11.4 Storage- and Transport Conditions 34
11.5 Service Life 34
11.6 Electromagnetic Compatibility (EMC) 35
12 Accessories and Spare Parts 39
13 Recycling and Disposal 40
14 Service and Maintenance 41
15 Explanation of Symbols used 42

AKITA® JET
4
1Introduction
These Instructions for Use contain information and safety precautions for the AKITA JET Inhalation
System. Before using your AKITA JET Inhalation System, read and understand the entire Instructions for
Use. Save these Instructions for Use for future reference. Please call the telephone number in section 14
if for any reason you do not understand any part of these Instructions for Use.
1.1 Intended Use
The combination of an AKITA JET control unit and a nebuliser set from the AKITA JET Year Pack are
intended for aerosol therapy of lower respiratory airways with inhalation solutions and suspensions. The
system is suitable for use at home, hospital and general practice for temporary oral inhalation of
inhalation solutions and suspensions prescribed or recommended by a physician.
The AKITA JET Inhalation System must be used only on conscious, cooperative patients from the age of
3 years onwards.
The system is not suitable for use in a healthcare environment with active HF Surgical Equipment and
the RF shielded room of a system for magnetic resonance imaging, where the intensity of
electromagnetic disturbances is high.
The AKITA JET Inhalation System guarantees a highly effective and rapid inhalation therapy for patients
ranging from infants to adults. The AKITA JET Inhalation System can be used for medication therapy of
lung diseases, such as bronchial asthma, chronic obstructive pulmonary disease (COPD) and cystic
fibrosis (CF).
•Children
oTreatment under supervision: 3 to 8 years
oTreatment after instruction: from 8 years
•Adults
oTreatment after physiotherapeutic instruction and in compliance with these Instructions
for Use.
The AKITA JET Inhalation System should be used with inhalation solutions and suspensions approved
for inhalation.
1.2 Liability
The AKITA JET Inhalation System is an electrically operated unit.
Unplug the power plug from the socket outlet to achieve full disconnection from the power supply.
It must neither be operated unattended nor in explosion hazarded or moist areas.

5
Accurate knowledge of and compliance with this Instructions for Use is required before the AKITA JET
Inhalation System is used.
The operator of the AKITA JET Inhalation System is liable to its safe functioning in all cases when it is
handled incorrectly.
It must be repaired only by Vectura or by a service depot expressly authorized by Vectura.
Only original AKITA JET accessories must be used for operation of the AKITA JET Inhalation System.
Vectura is not liable for any damage or malfunction resulting from incorrect use or from use for which
the device is not intended.

AKITA® JET
6
2Important Information for Your Safety
All safety precautions marked WARNING and/or CAUTION should be given special attention.
WARNING:
•Use the AKITA JET Inhalation System only for its intended use as described in these
instructions for use.
•If medications are being inhaled for the first time or for the first time at a higher dose, this
should be done under medical supervision only.
•Use the AKITA JET Inhalation System only when prescribed by a physician and only with the
medication prescribed for the AKITA JET Inhalation System. Follow the dosage of your
prescription. The use of other solutions and medications can lead to serious risks to health or
can damage the device.
•The Package Leaflet of the drug must also be read as it provides important safety information
and instructions about the medicinal product.
•When used in a home environment, the nebuliser may only be used by one single patient.
Nebulisers shall not be shared with other patients.
•When used in a hospital environment: Patients who are known to have an infection or are
carriers of pathogens, e.g. multi-resistant Staphylococci (MRSA), Burkholderia cepacia, etc.,
should always use only their own device and should inhale in a separate area from other
patients.
•Only use nebulisers which were cleaned and disinfected according to section 5. At multi
patient use the nebuliser must be sterilised according to section 7. Clean and disinfect the
nebuliser before first use.
•The AKITA JET Inhalation System is not designed for emergency and life supporting usage.
•The AKITA JET Inhalation System must not be used for patients who are breathing or being
ventilated via an endotracheal tube or a tracheal cannula.
•Do not leave children or infirm individuals unattended during treatment. Always use close
adult supervision when administering a treatment to a child or infirm individual.
•The dosage of your medication is set by a Smart Card (see section 6.5 and 8). Inhale your
medication with the corresponding Smart Card only.
•Do not use the device if it is damaged. Do not modify the device.
•Only use accessories described in these Instructions for Use. Only use the power supply
delivered with the control unit.
•When using multiple medications and Smart Cards, always ensure that the correct card for
the medication is inserted (see also section 8). Do not mix medication solutions.

7
•After each treatment session discard all excess medication (risk of contamination, potential
loss of potency of medication).
•The basic Smart Card supplied with the AKITA JET control unit is not designed for inhalation
of medications, and must be used for device testing and training only.
•To reduce the risk of contamination and strangulation, keep the AKITA JET Inhalation System
and all medications away from small children.
•The applied part is the nebuliser or the face mask and the first 10 cm of the tube.
•The AKITA JET Inhalation System should not be used around flammable substances, or in the
presence of a flammable anaesthetic mixture with air, oxygen or nitrous oxide.
•Do not use AKITA JET Inhalation System in a ventilator circuit
•Use the AKITA JET Inhalation System in a clean environment free from dirt, dust, pet hair, etc.
•Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment and
the other equipment should be observed to verify that they are operating normally.
•Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
•Do not use the Akita Jet in the bathroom.
•Do not use without the filter
•Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the AKITA
JET nebuliser, including cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
CAUTION:
•Only use the AKITA JET Inhalation System according to the EMC (electromagnetic
compatibility) information provided in the section 11.6.
•The AKITA JET Inhalation System may be affected by portable or mobile radio frequency
communication equipment. In case of malfunction or error messages, increase distance to
your cellular phone. Detailed information is provided in the section 11.6.
•Only use the AKITA JET Inhalation System with the approved accessories (see section 0). Non-
approved accessories may have a negative effect on the EMC (electromagnetic compatibility).
•The AKITA JET Inhalation System is not intended for continuous operation. The normal use is
up to 40 minutes.

AKITA® JET
8
3Getting Started
Check your AKITA JET Inhalation System packages to make sure that you have the following items.
AKITA JET Control Unit:
•AKITA JET Control Unit
•AKITA JET Power Supply
•Power Cord (suitable for the power supply in your country)
•Nebuliser Holder
•Carrying Handle
•Basic Smart Card
•AKITA JET Carrying Bag
•Instructions for Use
AKITA JET Year Pack:
•Two AKITA JET nebuliser sets, each set consisting of:
oNebuliser (nozzle attachment: orange)
oNebuliser tube
oHelp flow tube
oHelp flow adapter
oTubing clips
•Year Pack Instructions for Use
•Filter
A complete AKITA JET Inhalation System ready for use consists of the AKITA JET control unit and an AKITA
JET Year Pack.
These parts are needed for correct functioning of the AKITA JET Inhalation System.
If any of the equipment or accessories above is missing or damaged, please contact Vectura or your
service representative.

9
4Assembling AKITA JET Inhalation System
On each occasion before starting the equipment, as well as after periods of non-use, please comply
with the cleaning instructions in section 5. Ensure that the nebuliser set was cleaned, disinfected and, if
necessary, sterilised after the last treatment.
CAUTION:
•Make sure that the AKITA JET control unit is placed upright on a flat surface and that the air
ventilation slots on the backside are not blocked.
4.1 Connection of Power Supply and Power Cord
Fig. 1: Connect the power supply cable with the jack at the back
of the control unit.
Fig. 2: Connect the power supply with the power cord.
Plug the power cord into a suitable socket outlet.
4.2 Inserting Smart Card
Insert the Smart Card, which complies with the intended therapy into the card slot of the AKITA JET.
Make sure that the chip on the Smart Card is pointed down and that the arrow points in the direction of
the card slot. The card is correctly inserted when it is flush with the front of the control unit. Do not
switch on the device now.

AKITA® JET
10
Fig. 3: Inserting the Smart Card.
CAUTION:
•Make sure that you only inhale with Smart Cards that have been prescribed by your
physician.
•Please leave your Smart Cards inserted throughout your treatment with the AKITA JET and do
not remove the Smart Card until the therapy is finished, otherwise the data on the Smart
Card may be damaged. If you are inhaling only one medication with the AKITA JET, you can
leave your Smart Card inserted in the card slot of the AKITA JET control unit.
•The Smart Card must only be changed when the AKITA JET control unit is switched off.
For additional information regarding the AKITA JET Smart Cards see Section 8.
4.3 Nebuliser Assembly
Assemble the AKITA JET nebuliser set as shown in the following illustrations. Take care to prevent
damaging the individual parts.
Fig. 4: Nebuliser assembly
Gently push the nozzle attachment (orange, 1b) as far as it will go
onto the nozzle in the nebuliser lower section (1c) of the AKITA JET
nebuliser.
The arrow on the nozzle attachment must point upwards.
Now place the nebuliser upper section on the nebuliser lower
section and turn it clockwise to lock the two parts together.
4.4 Installing Nebuliser Holder
In order to simplify handling, the AKITA JET control unit is equipped with a holder for the nebuliser. The
nebuliser may be placed in the holder at any time.

11
Fig. 5: Insert the nebuliser holder into the relevant slot at
the back casing of the AKITA JET control unit.
Fig. 6: Place the nebuliser in the nebuliser holder.

AKITA® JET
12
5Cleaning and Disinfecting AKITA JET Inhalation System
The AKITA JET nebuliser is intended for repeated use. When used in a home environment the nebuliser
shall only be used by one single patient. To avoid any risk to health, e.g. infection from a contaminated
nebuliser, it is essential to comply with the following hygiene rules:
•The AKITA JET nebuliser must be cleaned after each treatment.
•The AKITA JET nebuliser must be disinfected once a day.
•Additional requirements concerning the necessary hygienic preparations (hand care, handling
of medications or inhalation solutions) in high-risk groups (e.g., patients with cystic fibrosis) can
be obtained from the respective self-help groups or your attending physician.
•Please check the parts of your AKITA JET nebuliser regularly and replace any defective (broken,
deformed or discoloured) parts.
5.1 Immediately after Use
Immediately after each treatment, all parts of the AKITA JET nebuliser must be cleaned of medication
residue and contamination. To do this:
•Disconnect nebuliser from tubing (tubing will not be cleaned).
•Discard excess medication.
•Disassemble the nebuliser into its individual parts as described in the following figure and rinse
under running tap water.
Fig. 7: Disassembling the nebuliser:
If the tubes (4 and 5) haven’t been removed already for
drying, remove tubes from the nebuliser.
Detach the mouth piece (2) from the nebuliser (1).
Unscrew the nebuliser (1).
Remove the nozzle attachment (1b) from the nebuliser
lower section (1c).
Remove the help flow adapter (3) from the nebuliser upper
section (1a).
5.2 Cleaning
The AKITA JET nebuliser must be cleaned after each treatment.
CAUTION:

13
•Use standard dishwashing detergent (for manual dish washing, neutral pH between 6 and 8)
without disinfection properties and without skincare additives (no balsam).
•Do not use of other cleaning detergents that may cause severe damage to the device or
impose health hazards such as detergents that have disinfectants, detergents with skin care
additives, detergents for dish washing machines, acids (such as vinegar), organic solvents
(such as isopropyl alcohol), or oxidizing agents (such as bleach).
Recommended Procedure:
•Fill a clean bowl with warm tap water (minimum temperature 35°C). Add standard dish washing
detergent (dosage according to the manufacturer's recommendations).
•Place the nebuliser components into the bowl. Clean all parts of the nebuliser thoroughly for
5 minutes using a soft brush or soft clean cloth.
•Then rinse all parts thoroughly under warm running water.
•To remove excess water you may shake the parts.
•Drain and place all parts on a new paper towel and let dry completely, or
•Continue with disinfection (see section 5.3).
5.3 Disinfection
The AKITA JET nebuliser must be disinfected once a day.
Recommended Procedure: Steam disinfector (Baby bottle disinfector)
•After cleaning the device according to the instructions above, place all components into the
steam disinfector. Make sure that the nebuliser remains disassembled.
•Operate the bottle disinfector according to the instructions of the manufacturer. Select a
minimum disinfection duration time of 6 minutes.
•After the disinfection cycle, open the lid of the steam disinfector to allow drying and cooling.
•Once the components are cool, place them onto a flat dry paper towel.
•Let the components dry completely (overnight).
Effective cleaning and disinfection were demonstrated by an independent accredited test laboratory
using the dishwashing detergent “Palmolive Original” (Colgate Palmolive GmbH, Hamburg, Germany)
and a steam disinfector (iQ24 Electronic Steam Steriliser, Philips AVENT, Suffolk, England, operated in
mode 1) used according to the recommended procedure described in these Instructions for Use. Use of
alternate disinfector devices or methods is in the responsibility of the user.
Possible Alternative: In boiling water
•After cleaning the device, fill a saucepan with distilled water.

AKITA® JET
14
•Place all components into the saucepan. Make sure that all components are submerged in
water.
•Boil the water for 5 minutes.
•Carefully remove the components from the saucepan.
•Shake the nebuliser components to remove excess water.
•Place the components onto a flat dry paper towel.
•Let the components dry completely (overnight).
CAUTION:
•Only the recommended disinfection method is validated. Boiling water cannot disinfect the
device as reproducible as the steam disinfector.
5.4 Storage, Transporting
•Make sure that the components have completely dried.
•Between uses and breaks in treatment, wrap the nebuliser in a clean, lint-free cloth (e.g. a tea-
towel) and keep it in a dry, dust-free environment.
•To carry the device around, you can clamp the carrying handle on the metal buttons on each
side on the control unit.
•For transporting, you may pack the AKITA JET Inhalation System in the carrying case provided
for this purpose.
•Keep the nebuliser in a dry, dust-free place protected from contamination.
5.5 Cleaning AKITA JET Control Unit
CAUTION:
•Switch off the AKITA JET control unit and unplug the power cord from socket outlet each
time before cleaning.
•To clean the AKITA JET control unit wipe the exterior of the housing with a damp cloth, and if
it is used by several patients also use a disinfecting cloth.
•To prevent damage to the electrical circuitry, NEVER spray liquids into the ventilation slots.
•If liquid has entered the case, contact Vectura or your service representative. Use your AKITA
JET Inhalation System only after advice from Vectura or your service representative (or after
an examination and possible repairs have been carried out).
5.6 Replacing Filter
•NEVER attempt to clean the control unit filter.
•The filter for the AKITA JET control unit must be changed at least once a year.

15
•Change the filter more frequently if the air quality where the device is used is poor (such as
from heavy cigarette smoking).
•Replace the filter if it becomes wet or damp.
To replace the filter:
•Remove the filter cover from the back of the device and remove the used filter from the air
inlet of the device (see figure below). Then insert the new filter into the recess and refit the
filter cover.
Fig. 8: Exchanging the filter.

AKITA® JET
16
6Taking Treatment
6.1 Filling the Nebuliser
Fig. 9: Open the AKITA JET nebuliser cap by pressing your
thumb against the underside of the cap.
Now prepare the inhalation solution. Follow the package leaflet that you received with your medication
and the dosage prescribed by your physician.
Fig. 10: Pour the quantity of medication prescribed by your
doctor into the nebuliser funnel (max. filling volume 8 ml).
Close the cap on the nebuliser upper section by clicking it into place.
WARNING:
Ensure that the medication level is not higher than the topmost mark on the scale. If it has been
overfilled, pour it all away and clean the nebuliser set (see section 5). Afterwards start again with filling
in the medication.
To prevent under dosage always fill in the complete medication as provided within the ampoule.
6.2 Connecting Tubes to the Nebuliser
The AKITA JET Inhalation System operates with two tubes, which have different connectors so that they
cannot be confused.

17
Fig. 11: Attach the help flow adapter to the upper opening of
the nebuliser and connect the help flow tube.
Fig. 12: Hold the nebuliser upright and attach the nebuliser
tube to the nebuliser bottom.
6.3 Connecting Tubes to the Control Unit
The AKITA JET nebuliser is connected to the control unit via help flow tube and nebuliser tube. The help
flow tube supplies you with a constant flow of air during inhalation.
The nebuliser tube supplies the compressed air for atomizing the medication through the nebulising
nozzle.
Fig. 13: Attach the nebuliser tube to the lower connection of the
AKITA JET control unit.
Fig. 14: Attach the black end of the help flow tube to the upper
connection of the AKITA JET control unit.

AKITA® JET
18
Finally attach the mouth piece to the nebuliser upper section. Your AKITA JET Inhalation System is now
prepared for the treatment.
CAUTION:
•Check before every inhalation and during treatment, that the tubes are connected as shown
in the following figure.
Fig. 15: AKITA JET with connected nebuliser.
6.4 Switching on AKITA JET Inhalation System
Before every inhalation, check that the nebuliser is correctly assembled.
Ensure that the device is connected as described in the previous section, that a filter is inserted (see
section 5.6) and the Smart Card is correctly inserted (see section 4.2).
CAUTION:
•Always ensure when operating the AKITA JET Inhalation System that the ventilation slots at
the back of the control unit remains unobstructed. Never cover the control unit during use.
•Switch on the AKITA JET Inhalation System with the on/off button.
•The treatment time for normal use is up to 40 minutes.
Fig. 16: Button for switching on the AKITA JET.
•Wait until the AKITA JET Inhalation System has completed the self-test.
•During the self-test, the compressor functionality and the connection of the help flow tube is
tested. During this time, the display shows the following message:
AKITA JET X.X
Auto-test on
Please wait…
•After the self-test the display will show you the following message:

19
Only use a clean
and disinfected
nebuliser!
6.5 Setting Inhalation Time (per breath)
The inhalation time defines the time for one inhalation (without expiration).
Your health care provider will usually determine the optimal inhalation time for you by a lung function
test. The best way to test this is by a test inhalation with the AKITA JET Inhalation System with your
health care provider.
Your health care provider can individually adjust the inhalation time with the "vol." key.
You may change the inhalation time setting any time that your lung function has changed (such as
during illness or infection).
Fig. 17: Key for setting the inspiration time.
•You can select 10 different inhalation times between 1.5 s and 8.0 s with the “vol.“ key.
•The inhalation time is increased one step every time the key is pressed.
•To decrease the inhalation time, press the key until the first setting is shown.
•The display shows the selected inhalation time with the corresponding volume.
Substance/Dosage
X.X s – X.X l
XXXX breaths
START>INHALE
or
Substance/Dosage
X.X s – X.X l
number breaths
free START > INHALE
The last selected inhalation time is saved on the Smart Card. This means that the setting is only required
at the first inhalation.
If you switch on the AKITA JET Inhalation System with the Smart Card again, your last selected
inhalation time will be automatically displayed.
6.6 Medication Selection
If a Smart Card intended for different medications is used, after the self-test the following display is
shown for 5 seconds or until a key is pressed:
Press KEY to
select operation mode
To select a medication, press the “med.“ key until the display shows the desired medication.

AKITA® JET
20
Fig. 18: Key to select a medication. This key is only required if special Smart Cards
intended for different medication inhalations are used.
6.7 Inhalation
If several or different medications are inhaled in turn within the scope of inhalation treatment, remove
the remaining medication solution from the nebuliser after every use and rinse it briefly with water.
Before you start your inhalation treatment, please comply with the following instructions:
•Sit in a relaxed and upright position. Sit in a position from which you can see the display and
keep the nebuliser upright.
•Exhale and then take the mouthpiece between your teeth and enclose it completely with your
lips.
•Watch the AKITA JET control unit display carefully particularly during your first few
inhalations. If you breathe in too fast, the display will show "inhale slowly“. This message
shows that you are inhaling faster than the optimum flow pre-set by the AKITA JET Inhalation
System. Try to inhale more slowly until the message “inhale slowly” no longer appears.
•Do not block the mouthpiece with your tongue during inhalation.
•Note how the AKITA JET Inhalation System exerts a light pressure for optimum delivery of the
medication to your lungs.
•Make sure that medication aerosol does not escape through your nose during inhalation.
•Take the mouthpiece out of your mouth and breathe out into the room air. Do NOT breathe
out through the mouthpiece. Alternatively you can keep the mouthpiece in your mouth and
breathe out through your nose.
Inhalation will not start until the device confirms that you are inhaling through the mouthpiece.
1. Breathe in slowly through the mouthpiece. Breathe in for a short time only, and then the inhalation
flow of the AKITA JET Inhalation System will start.
2. While inhaling, let yourself be guided by the constant air flow of the AKITA JET. Avoid allowing the
aerosol to escape through your nose during inhalation. Please note the information on the display.
With correct inhalation, the following display appears:
Inhale for
xxx more seconds