DTF PURENEB AEROSONIC: PURENEB AEROSONIC+ User manual

A.NU.EN.008.0219
INSTRUCTIONS FOR USE
PURENEB®NEBULIZING SYSTEMS
associated with PURENEB EXTRANEB and EXTRANEB SONIC nebulizing kits:
NL9 range –NL11S range
(adult and paediatric models)
According to the European Standard “Nebulizing systems” EN 13544-1
Directive 93/42/EEC –Medical Devices Class IIa
« CLASSIC » OR STANDARD MODELS:
FOR LUNG OR BRONCHIAL TREATMENTS
AEROBOX (ref. ABOX) 0459 (1998)
AEROBOX+ (ref. ABOX+) 0459 (2001)
« SONIC » MODELS:
FOR ENT & SINUSITIS TREATMENTS
AEROSONIC (ref. AOHBOX) 0459 (2006)
AEROSONIC+ (ref. AOHBOX+) 0459 (2011)
Non contractual pictures
LA DIFFUSION TECHNIQUE FRANCAISE
19 rue de la Presse CS 60132 42003 SAINT-ETIENNE Cedex 1 France
Tel. [phone] - Fax [phone] - e-mail : [email protected] -www.dtf.fr
Video « How to use your
Atomisor nebulizing system » is
available on www.dtf.fr

2/12
CONTENTS
1. CLASSIFICATION and ELECTROMAGNETIC COMPATIBILITY
2. PRESENTATION
2.1. Classic aerosols = without sound vibrations
2.2. Sonic aerosols = with 100 Hz sound vibrations
2.3 Identification
2.4. Symbols used on devices
3. PRECAUTIONARY MEASURES
4. DESCRIPTION AND PERFORMANCES
4.1. AEROBOX and AEROBOX+ models
4.2. AEROSONIC and AEROSONIC+ models
4.3. Lists of accessories and spare parts
4.4. Performances according to the European Standard
EN 13544-1 "Nebulizing systems"
5. DIRECTIONS FOR USE
6. CLEANING AND DISINFECTION
7. FAILURES REMEDIES AND WARRANTY
8. WASTE DISPOSAL
DO NOT FORGET!

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1. CLASSIFICATION and ELECTROMAGNETIC COMPATIBILITY
Device class
IIa
Device class in electrical safety
II
Type of applied parts
BF
Protection level
IP 30
3: protected against ingress of solid foreign objects larger than
2.5 mm;
0: not protected against vertical water drops falls.
Expected shelf life of accessories
1 year
Expected shelf life of the device
5 years
Weight ABOX / ABOX+
AOHBOX / AOHBOX+
3,8 kg
4,5 kg
Dimensions
L360xl250xh180 mm
Voltage
230 V; 50 Hz (ABOX can be available in 220V-50Hz, 220V-60Hz
or 240V-50Hz)
Consumption ABOX
ABOX+
AOHBOX / AOHBOX+
85 VA
105 VA
110 VA
Using pressure ABOX / AOHBOX
ABOX+ / AOHBOX+
> 400 hPa
> 650 hPa
Sound level
< 70 dBa
Flow rate ABOX / AOHBOX
ABOX+
AOHBOX+
5.15 L/min
6.85 L/min
6.50 L/min
Running mode
Intermittent (30 min ON / 30 min OFF)
Room temperature (T) - Transport and storage
-25°C < T < +70°C
Room temperature (T) - Operating
+5°C < T < +40°C
Relative humidity (H) - Transport, storage and operating
15% < H < 93%
Atmospheric pressure (P) - Transport, storage and operating
700 hPa < P < 1060 hPa
Essential performances: provide pressure allowing to transform the medicine into aerosol.
Applied part: mouth piece, nasal piece or mask
Note: The CE certificate can be supplied on request.
ELECTROMAGNETIC COMPATIBILITY
Electro medical devices require special precautions against EMC and must be installed and set to operate
in accordance with the EMC information provided in this manual.
WARNING: Avoid using this unit near or stacked onto other equipment as this may cause a malfunction. If
this is necessary, this appliance and the other appliances should be monitored for normal operation.
WARNING: Use of accessories, transducers and cables other than those specified or supplied by the
manufacturer of this device may cause an increase in electromagnetic emissions or a decrease in the
immunity of this device and cause improper operation.

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WARNING: Portable RF communication devices (including peripherals such as antenna cables and external
antennas) should not be used closer than 12 inches (30 cm) to any part of the PURENEB device, including
cables specified by the manufacturer. Otherwise, performance may be impaired.
WARNING: If the device malfunctions due to electromagnetic disturbances, the performance of the device
may be impaired and result in delayed patient care.
Wireless communication devices such as wireless home networking devices, mobile phones, cordless
phones and their bases, walkie-talkies can affect the device, and it is recommended to keep them at a
distance of at least 0.5 m from the device.
Guidance and manufacturer's declaration –electromagnetic emissions
Emissions test
Compliance
RF emissions - CISPR 11
Group 1
RF emissions - CISPR 11
Class B
Harmonic emissions - IEC 61000-3-2
Class A
Voltage fluctuations / flicker emissions - IEC 61000-3-3
Complies
Guidance and manufacturer's declaration –electromagnetic immunity
Immunity test
IEC 60601
test level
Compliance level
Electrostatic discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV
± 15 kV
Electrical fast transient / burst
IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input/output lines
± 2 kV
± 1 kV
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
0% UT; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and
315°
0% UT; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and
315°
0% UT; 1 cycle
AND 70% UT; 25/30 cycles
Single phase : at 0°
0% UT; 1 cycle
AND 70% UT; 25/30 cycles
Single phase : at 0°
Voltage interruptions
IEC 61000-4-11
0% UT: 250/300 cycles
0% UT: 250/300 cycles
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
30 A/m
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2,7 GHz
10 V/m
80 MHz to 2,7 GHz
385 MHz at 27 V/m
450 MHz at 28 V/m
710, 745, 780 MHz at 9 V/m
810, 870, 930 MHz at 28 V/m
1720, 1845, 1970 MHz at 28 V/m
2450 MHz at 28 V/m
5240, 5500, 5785 MHz at 9 V/m
385 MHz at 27 V/m
450 MHz at 28 V/m
710, 745, 780 MHz at 9 V/m
810, 870, 930 MHz at 28 V/m
1720, 1845, 1970 MHz at 28 V/m
2450 MHz at 28 V/m
5240, 5500, 5785 MHz at 9 V/m
Conducted RF
IEC 61000-4-6
3V
0,15 MHz –80 MHz
6V in ISM bands and amateur radio bands
between 0.15 MHz and 80 MHz
80% MA at 1kHz
3V
0,15 MHz –80 MHz
6V in ISM bands and amateur radio bands
between 0.15 MHz and 80 MHz
80% MA at 1kHz

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2. PRESENTATION
What is an aerosol?
An aerosol is an air suspension of very fine medicinal particles.
Their size is below 10 microns.
Depending on the treatment, the device will be used as a classic
aerosol or as a sonic aerosol.
2.1. Classic aerosol = WITHOUT SOUND VIBRATIONS
AEROBOX –AEROBOX+ models
The particles fineness ensures a penetration till the alveoli of the lungs.
Their diameter is some micrometers.
The classic aerosol is used for broncho-pulmonary treatments: Asthma, Cystic Fibrosis, Tracheitis,
Chronic Obstructive Pulmonary Disease (COPD), Pneumocystosis (Pneumocystis Jirovecii infection),
Pneumonitis.
The classic compressors are equipped with the EXTRANEB+ minidose nebulizing kit ref. NL9MXBR. They
also can be used with our other EXTRANEB CLASSIC nebulizing kits only.
For the Tobramycine nebulization, the EXTRANEB+ minidose nebulizing kit (with selector) must be used
with the AEROBOX+compressor.
2.2. Sonic aerosol = WITH 100 Hz SOUND VIBRATIONS
AEROSONIC –AEROSONIC+ models
An aerosol stream subjected to sound vibrations around 100 Hz is called "sonic aerosol".
The fineness of the particles is unchanged.
Aerosol particles are submitted to 100 Hz sound vibrations in order to modify their motion, i.e. the only
means to allow their penetration into the sinuses.
To allow the penetration of the aerosol particles, it is necessary to alternate (automatically or
manually) periods with vibrations (15 sec.) and periods without vibrations (15 sec.).
Pathologies: Rhinosinusitis, Sinusitis, Laryngitis.
The sonic aerosol compressor can be easily used in classic or in sonic mode, according to the treatment
wanted.
The sonic compressors are equipped with the EXTRANEB SONIC nasal nebulizing kit (ref. NL11SN). They
also can be used with EXTRANEB SONIC nebulizing kits only.
For sinusitis, a nose end-piece is recommended.
2.3. Identification
Each device has its own identification code (reference and unit) showing the manufacturing date,
manufacturing order and personal code.
Example: 68 078 HE 03
68: manufacturing year (68: 1950 + 68 = 2018)
078: day of the year
HE: personal code
03: number of order (in a series)
NASAL PIECE C26
The aerosol penetrates
directly through the nose.
SONIC
CLASSIC

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2.4. Symbols used on devices
Device type BF Device class 2 (electric) See instructions for use Manufacturer Dangerous
voltage
Caution / Warning Serial number Alternative current Device reference
Keep dry Fragile Keep away from light Off Classic Modus Sonic Modus
3. PRECAUTIONARY MEASURES
Aerosol treatments can only be done on medical prescription and within the prescribed doses.
Carefully keep these instructions for use as it provides necessary information for the good use of the
equipment.
Before connecting the device to the mains, check the values on the device (volts and Hz) and your
distribution network.
The warranty does not cover faulty connections.
Fragile medical device, to be manipulated with care.
Keep this medical device out of the reach of children or animals (potential risks with the tubes and
detachable part of the nebulizing kit).
Connect the device to an easily accessible plug, to allow a rapid disconnection from the mains.
The device has to be installed and put into service according to the information supplied with the
attached documents.
IMPORTANT REMARKS
Before connecting the device to the electric power supply, make sure that the nebulizing kit is
connected to the unit in order to avoid an abnormal noise.
If the compressor with the nebulizing kit is noisy, do not hesitate to contact your supplier.
Do not exceed 6 ml medicine in the nebulizing kit EXTRANEB+ MINIDOSE (NL9M) and EXTRANEB SONIC
NASAL (NL11SN).
Do not exceed the mark “full” printed on the nebulizing kits EXTRANEB and EXTRANEB SONIC.
Clean if necessary the jets of the nebulizer with hot water, without using any metal wire.
A modification of jets dimensions can have a bad effect on the particle size and on the therapeutic
aerosols efficiency.
Each nebulizing kit is intended for a single patient.
Caution: before using the device, make sure that the nebulizing kit is well mounted.
Check the jet is not clogged.
Caution: This medical device is directly connected to the electric power supply, do not use it in bath or
under the shower, do not immerse.
Keep this medical device away from any high heat source.
Store properly the electric cord and the tubes after each use.
Pureneb devices are designed to operate at altitudes less than or equal to 3 000 meters.
No special knowledge or training is required to use Pureneb devices.
The electric cord cannot be replaced by the maintenance staff.
An animal can eat the electric cord. Thoroughly check the state of the equipment before use.
O
I
II

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The patient is an intended operator. He can use all functions of the device safely.
Contact the manufacturer if you need help to set up, use or maintain the medical device and to report
any unexpected operation or event.
PARTICULAR WARNINGS
Do not open the device when connected to the main (electrical shock hazard).
Side effects: for corticoids, it is better to use a mouth or nose piece. Otherwise, if the mask is used, it is
recommended to rinse one's face and/or mouth after the session. Refer to the medicine instructions
for use.
Side effects: a risk of allergy of the body parts in touch with the mask or nose/mouth pieces can
appear.
Performances supplied by the manufacturer may not apply to drugs in suspension or in very viscous
form. In that case, it is necessary to check with the supplier of the drug.
This device is to be used in health care establishment or at home.
Do not use the device outdoors, near a heat source or near a waterhole (bathtub, sink…).
After use, disconnect the device from the mains.
Make sure the device is not exposed to direct sunlight or excessive heat.
Do not touch the device for more than 10 seconds during use.
Do not touch the tube for more than a minute during the device use (its temperature can reach 54 °C
maximum in case of defect).
The mains plug is the disconnecting device and must always be accessible.
Devices not to be used in presence of a mixture of inflammable anaesthetic with air or oxygen or
nitrous oxide.
HOW TO INHALE?

The patient should be relaxed, seated in an upright position.

Breathe deeply: * through the mouth with a classic aerosol, using rather the mouth piece,
for broncho-pulmonary treatments.
* through the nose with a sonic aerosol, using rather the nose piece, for
ENT treatments.

After each deep inspiration, hold your breath and then slowly exhale. Respect generally a minimal
10 minutes-duration to allow a good aerosols deposition in respiratory ways.
The nebulizing duration can be reduced with the AEROBOX+ or AEROSONIC+ units.
IN ALL CASES YOU HAVE TO FOLLOW YOUR MEDICAL PRESCRIPTION
Video « How to use your Atomisor nebulizing system » is available
and can be downloaded on www.dtf.fr

8/12
4. DESCRIPTION and PERFORMANCES
Caution: Check the kneecap is well assembled on the mask.
CLASSIC AEROSOL COMPRESSORS
(Broncho-pulmonary treatments)
4.1. AEROBOX and AEROBOX+
EXTRANEB+ NL9MXBR nebulizing kit with
mouth piece and mask
Carrying bag on request: ref. MBOXA
SONIC AEROSOL COMPRESSORS
(ENT treatments)
For a broncho-pulmonary treatment, the Sonic Aerosol compressor is used in classic mode (without
vibrations) and can be equipped with the EXTRANEB nebulizing kit (with mouth piece), ref. NL9M.
4.2. AEROSONIC and AEROSONIC+ with automatic control
EXTRANEB SONIC nasal
NL11SN-GB nebulizing kit
with nasal piece + mask
Switch
(with sound vibrations or without, stop)
Carrying bag on request: ref. MBOXAS
4.3. List of accessories and spare parts
Accessories:
Extraneb+ nebulizing kit with adult mask and mouth piece, ref. NL9MXBR
Extraneb+ nebulizing kit with paediatric mask and mouth piece, ref. NL9MXBP
Extraneb+ nebulizing kit with adult mask, ref. NL9MXR
Extraneb+ nebulizing kit with paediatric mask, ref. NL9MXP
Extraneb+ nebulizing kit with mouth piece, ref. NL9MXB
Extraneb Sonic nasal nebulizing kit with adult mask and nasal piece, ref. NL11SN-GB
Extraneb Sonic nasal nebulizing kit with paediatric mask and nasal piece, ref. NL11SNP-GB

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Spare parts:
Mouth piece, ref. C27D
Nasal piece, ref. C26
Adult mask, ref. R
Paediatric mask, ref. RP
Infant mask, ref. RBB,
Mask for tracheotomy, ref. RT
Tube 6x9, 1 metre, ref. C20P
Tube 8.5x12, 1 metre, ref. T2 (for sonic nebulizing kit)
4.4. Performances according to the European Standard EN 13544-1 "Nebulizing
systems"
Information related to the filling volumes, the inhalable mass and to the produced aerosol flow are
indicated with the nebulizing kit.
Granulometry: the granulometric distribution depends on the nebulizing system: compressor +
nebulizing kit.
Examples:
CLASSIC ATOMISOR for broncho-pulmonary treatment:
PERFORMANCES
EXTRANEB NL9M NEBULIZING KIT
WITH AEROBOX+ DEVICE
EXTRANEB NL9M NEBULIZING KIT
WITH AEROBOX DEVICE
MMAD
3.9µm
4.4µm
GRANULOMETRIC
CURVE
NL9M - ABOX+
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
0,1
1
10
100
Diamètre aérodynamique (µm)
% cumulé
NL9M - ABOX+
SONIC ATOMISOR for ENT treatment:
PERFOR-
MANCES
NL11SONIQUE NEBULIZING
KIT WITH AEROSONIC+
DEVICE
NL11SN NEBULIZING KIT
WITH AEROSONIC DEVICE
AND NASAL PIECE
NL11SONIQUE NEBULIZING
KIT WITH AUTOSONIC DEVICE
MMAD
4.8µm
3.1µm
5.5µm
GRANULO-
METRIC
CURVE

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5. INSTRUCTIONS FOR USE
FOR A GOOD HYGIENE:
Before the first use, disinfect your jet nebulizing kit in boiling water
(20 minutes). Require it in its original packaging.
Wash your hand carefully before each inhalation session.
Connect the kit tube(s) to the unit outlet(s) according to the
instructions for use that you will find on the compressor and in the
kit’s box.
Take off the upper part of the nebulizing kit by unscrewing it and pour medication
in the tank without exceeding the “full” mark (3,5 ml for 10 min.). Put back the
upper part.
Switch on the compressor (switch on I).
Only for sonic aerosols:
Automatic control: switch on "sonic aerosol" position. Sound vibrations automatically alternate with
periods without sound vibrations.
AFTER AN AEROSOLS TREATMENT:
Switch off the compressor (switch on O).
Disconnect both tubes of the nebulizing kit.
Rinse the nebulizing kit with hot water.
Let it dry.
Follow the instructions printed on the box for the dismantling of the
PURENEB® nebulizing kit.
PURENEB®nebulizing kits support the dishwasher and the boiling water.
Make sure that the jet is correctly inserted.
6. CLEANING AND DISINFECTION
Never use ether or solvent like acetone.
The cleaning with alcohol is authorized.
CLEANING OF THE COMPRESSOR
After each use, cleaning is limited to external parts, using a non-abrasive sponge soaked with alcohol or
with a disinfecting product recommended by the manufacturer (Anios Surfa'safe Premium).
Jet