Page 1
PROFESSIONAL MEDICAL PRODUCTS
AEROSOL MISTRAL
MISTRAL NEBULIZER
NÉBULISEUR MISTRAL
MISTRAL NEBULIZADOR
INALADOR MISTRAL
MISTRAL INHALATOR
28102
Gima S.p.A.
Via Marconi, 1
20060 Gessate (MI) Italy
gima@gimaitaly.com
export@gimaitaly.com
www.gimaitaly.com
M28102-M-Rev.4-09.20
Made in Italy
0476
Page 2
15
Aerosol Mistral is a system for aerosol therapy, with 230V ~ / 50Hz power supply, intended
for household use.
The appliance is designed for non-continuous use (Ton: 20 mins / Toff: 40 mins).
The medical device is designed to be easy to transport and use and is indicated for nebulizing bronchodilators and antibiotics. Made of plastic housing with high heat and electrical
insulation in accordance with the European safety standards.
ENGLISH
GENERAL INSTRUCTIONS
• CAREFULLY READ THE MANUAL BEFORE USE
• FOR DRUG INHALATION ALWAYS FOLLOW MEDICAL ADVICE
• DO NOT DISASSEMBLE THE APPLIANCE. FOR ANY INTERVENTION, CONTACT THE
TECHNICAL SERVICE OF THE DISTRIBUTOR AND/OR GIMA’s TECHNICAL SERVICE
• REMOVE THE APPLIANCE FROM THE TRANSPORT BAG BEFORE EACH USE
BASIC SAFETY STANDARDS
1.
When opening the packaging, check the integrity of the appliance by paying particular attention to the presence of damage to plastic components which may disclose internal live
parts of the appliance and to breakage and/or stripping of the power cable. In this case,
do not connect the plug to the socket. Carry out these operations before each use.
2. Before connecting the appliance, always check that the electrical data indicated on the
label and the type of plug used correspond with the data of the power network to which
it is intended to be connected.
3. Do not leave the appliance plugged unnecessarily: disconnect the plug from the power
network if not used.
4. Comply with the safety standards for electrical appliances. In particular:
- Use only original accessories and components supplied by Gima S.p.A. in order to
ensure utmost efciency and security of the device.
- Never immerse the appliance in water.
- Place the appliance on at and stable surfaces in order to avoid obstructing the cooling openings located on its sides.
- Do not use the appliance in environments with the presence of ammable anesthetic
mixture with air, oxygen, or nitrous oxide.
- Do not use the appliance with anesthetic and respiratory equipment.
- Avoid touching the appliance with wet hands.
- The use of this appliance by children and/or people with disabilities shall be closely
monitored by an adult with full mental capacity.
- Disconnect the appliance from the power supply if not used.
- Do not pull the power cable to disconnect the plug. Grab the plug with the ngers to
pull it out from the power network.
- Store and use the appliance in environments protected by atmospheric agents and
away from heat sources. After each use, it is recommended to store the device inside
its box away from dust and direct sunlight.
- In general, it is not recommended to use simple or multiple adapters and/or extension
cables. If their use is essential, it is necessary to use devices in compliance with the
safety standards, paying attention not to exceed the maximum power limits indicated
Page 3
ENGLISH
on the adapters and on the extension cables.
5. For repair works contact only Gima’s technical service or a technical center authorized
by the manufacturer. The device requires the use of original spare parts. Failure to comply with the above may compromise the safety of the appliance.
6. This appliance shall be solely intended for the use which was designed for and
according to the instructions of this manual. Therefore, it shall be used as aerosol
therapy system. Any other use is improper and therefore hazardous; the manufacturer
shall not be deemed responsible for damage caused by an improper use or if the appliance is used in electrical installations that do not comply with the safety regulations in
force.
7. The medical device requires specic precautions in terms of electromagnetic compatibility and shall be installed and used according to the instructions provided along with
the accompanying documents: the Mistral device shall be installed and used away from
portable and mobile RF communication devices (mobile phones, transceivers, etc.)
which may affect the appliance.
8. Some components of the appliance are of small size and might be swallowed by children; keep the device out of reach of children.
9. Keep the accessories out of reach of children. Children and dependents shall always
use the medical device under the close supervision of an adult with full mental capacity.
Keep the ampoule out of reach of children under 36 months as it contains small parts
which be may swallowed.
Do not leave the device unattended in areas accessible to minors and / or people
with disabilities.
10. Do not leave the device unattended in areas accessible to minors and / or people with
limited mental capacity as they may be strangled with the air hose.
11. The patient can come into contact with the medical device through the nebulizer /
masks / mouthpiece and /or nosepiece. These components comply with the requirements of ISO 10993-1, therefore neither allergic reactions nor skin irritation can occur.
12. The product and its parts are biocompatible in accordance with the requirements of EN
60601-1.
13. The device is easy to use. No additional precautions other than the instructions of this
manual of use are required.
14. WARNING: Do not alter this appliance without the authorization of Gima S.p.A..
No electrical and / or mechanical part which the device consists of has been designed
to be repaired by the user.
Failure to do so can compromise the safety of the appliance.
15. The use of the medical device in environmental conditions other than those illustrated in
this manual may jeopardize the safety and the parameters of the appliance.
16. The materials used for the contact with drugs are thermoplastic polymers with high
chemical stability and resistance.
Such materials have been tested with commonly-used medications (Salbutamol, Be-
clomethasone Dipropionate, Acetylcysteine, Budesonide, Ambroxol) and no interaction
has been reported. Nonetheless, given the variety and the ongoing evolution of the medicines used, potential interactions cannot be ruled out. Therefore, it is recommended to:
- Use up the drug as quickly as possible after its opening.
- Always avoid prolonged contact of the drug with the container. Clean the container
immediately after its use.
- In the event of anomalous situations (e.g. softening or cracks) of the container, do not
16
Page 4
17
introduce any solution and do not inhale. Contact the technical service, specifying the
methods of use and the type of drug used.
17. Remember to:
- use this appliance only with medicines prescribed by your doctor;
- perform the treatment by using only the accessory instructed by your doctor accord-
ing to the disease.
Under certain fault conditions, the packaging temperature can raise and there might
be risk of burns if the user comes into contact with such parts. In any event, the temperatures do not exceed the limit of 105°C [221°F] (ref. Interpretation Sheet IEC 60601-1).
Gima S.p.A. cannot be held liable for accidental or indirect damage resulting
from alterations of the device, repairs and/or unauthorized technical interventions, or
damage to any of its part due to accident, misuse and/or abuse.
Any unauthorized intervention on the device, even the slightest one, will immediately invalidate the warranty and does not ensure the compliance with the technical and safety requirements provided by Directive MDD 93/42/EEC (and subsequent
amendments) and by the related reference standards.
ENGLISH
PRODUCT SPECIFICATIONS
TYPE (Directive 93/42/EEC) Medical device Class IIa
MODEL Mistral
POWER SUPPLY 230V~ / 50Hz
ABSORBED POWER 170 VA
FUSE F 1 x 2A L 250V
MAXIMUM PRESSURE 250 kPa (2.5 Bar)
MAXIMUM FLOW (in the compressor) 14 L/min
OPERATING PRESSURE 110 kPa (1.10 Bar)
OPERATIONAL FLOW 5.0 L/min at 110 kPa
ATOMIZATION 0.35 ml/min (with 4ml solution NaCl 0.9%)
MMAD (measured in accordance
with EN 13544-1)
GSD 2.87
WEIGHT 1.10 Kg
SIZE 130 (L) x 89 (H) x 146 (P) mm
MAXIMUM NOISE LEVEL 60 dB (A)
FUNCTIONING Ton: 20min / Toff: 40min
MINIMUM NEBULIZER VOLUME LEVEL 2ml
MAXIMUM NEBULIZER VOLUME LEVEL 6ml
2.44
Page 5
ENGLISH
18
OPERATING CONDITIONS Room temperature: 5 ÷ 35°C
STORAGE AND TRANSPORT
CONDITIONS
Copy of the EC Declaration of conformity can be requested to Gima S.p.A. - Via Marconi,
1 - 20060 – Gessate, Milan (Italy)
MMAD = Mass Median Aerodynamic Diameter
GSD = Geometric Standard Deviation
NB: The measures and the curves are not valid in the event of medications supplied in high
viscosity suspension.
CLEANING OF THE APPLIANCE
The cleaning of the device shall be carried out with a soft and dry cloth and with non-abrasive detergents. Do not use excessively wet cloths as the contact of liquids with the electrical parts of the appliance may cause malfunctions or may be hazardous.
While cleaning the device, make sure that no liquids get inside the appliance and
that the power outlet is disconnected.
Wait for the device to dry off before storing or using it again.
Percentage of humidity in the environment:
15 ÷ 93% RH
Atmospheric pressure: 700 ÷ 1060 hPa
Room temperature: -25 ÷ 70°C
Percentage of humidity in the environment:
0 ÷ 93% RH
Atmospheric pressure: 500 ÷ 1060 hPa
Page 6
19
MAINTENANCE
The Mistral device does not have any part that requires maintenance and/or lubrication.
Nonetheless, it is necessary to carry out some checks to verify the function and security of
the appliance before each use. Remove the appliance from the box and always check that
there is no visible damage; particular attention should be given to any cracks in plastics
which may leave some electrical components exposed. Check also the integrity of the power cable which might have been damaged during the previous use.
Then connect the cable to the power network and switch it on. Close the compression cap
with one nger and check that there are no disturbing noises which may be evidence of
malfunction.
Check that the nebulizer has not suffered any breakage during the previous use (it was
stored inappropriately or has suffered impacts). The appliance is protected by a protection
fuse (F 2A L 250V) not accessible from outside. Therefore, contact the technical staff authorized by the manufacturer for its replacement.
Type of defect Cause Corrective action
1. Poor atomization. Clogged ampoule. Clean and disinfect the ampoule as set
2. Poor atomization. Clogged ampoule. If the washing had no positive out-
3. Lack of
atomization.
4. Slow atomization. Excessive oily drug. Dilute the drug with saline.
5. Noisy device. Prolonged use. Contact the reseller or Gima’s technical
6. The Device
does not work.
Defects 1 - 2 - 3 4 - 5 - 6
If the appliance still does not nebulize after having checked the above mentioned conditions, it is recommended to contact the reseller or Gima’s technical service.
BEFORE CARRYING OUT ANY CHECKS IN THE EVENT OF ANOMALIES OR
MALFUNCTIONS, CONTACT GIMA’S TECHNICAL SERVICE. THE MANUFACTURER
OFFERS NO GUARANTEE FOR THE APPLIANCES WHICH HAVE ASSESSED AS TAMPERED AFTER THE CHECKS CARRIED OUT BY THE TECHNICAL SERVICE.
Nozzle stuck.
Defective power cable
Broken and/or absent
power source.
None of the corrective
actions has been effective
ENGLISH
out in the manual.
come, replace the ampoule.
Press hard the nozzle (cylindrical im-
mersion tube) placed inside the polycarbonate ampoule bottom with a nger.
service.
Replace the power cable.
Check the power source and voltage.
Contact the reseller or Gima’s technical
service.
CLEANING AND WASHING OF ACCESSORIES
Before each use and / or after the cleaning operations, check the integrity of all accessories
supplied with the device. Turn off the device before each cleaning operation and disconnect
the power cable from the socket.
Page 7
ENGLISH
PREPARATION
1. Pull out the air hose from the nebulizer leaving it plugged to the air outlet pipe of the
device.
2. Rotate the upper part of the nebulizer anticlockwise.
3. Disconnect the internal pisper at the bottom of the nebulizer with nger force.
CLEANING
Clean all the components of the nebulizer (except the air hose) before and after each use by
choosing one of the methods described below.
Method 1: Thoroughly clean the components for 5 minutes by using hot drinking tap water
(around 40°C – 104°F) and neutral soap.
Method 2: Clean the components (except the air hose) by immersion in a solution of 60%
of water and 40% of white vinegar. At the end of the operation, rinse with plenty of hot
drinking water (around 40°C – 104°F).
At the end of the cleaning operations, rinse thoroughly by removing excess water and allow
to air-dry in a clean spot.
DO NOT BOIL OR AUTOCLAVE THE AIR HOSE AND THE MASKS
DO NOT WASH THE ACCESSORIES IN THE DISH WASHER
WASHING
Where diseases with risk of infection and microbial contamination are present, the end user
shall carry out the washing operations properly. The washing procedure can be performed
only if the components have been previously cleaned (see cleaning section).
For the washing procedure, the following operations shall be carried out:
- Fill a container of suitable size to hold every individual component with drinking water and
disinfectant (hypochlorite solution easily available in pharmacies) by complying with the
proportions indicated on the disinfectant packaging.
- The immersion time in the solution is indicated on the packaging of the hypochlorite solu-
tion according to the concentration chosen for the preparation of the solution.
- Rinse with plenty of warm drinking water until removing any trace of solution, dry and
store in a dry and dust-free place.
- Dispose the solution used according to the instructions provided by the manufacturer of
the disinfectant.
20
SUPPLIED ACCESSORIES
ACCESSORIES
HI-FLO accessories kit
(HI-FLO ampoule, Adult Mask, Children Mask,
Air hose, Mouthpiece and Nosepiece)
Air lter (+2 spare parts)
Transport bag
Page 8
21
ENGLISH
1 – Air hose
2 – Ampoule lower part
3 – Nebulizer Nozzle
4 – Ampoule upper part
5 – Mouthpiece
6 – Adult Mask
7 – Children Mask
8 – Nosepiece (non-invasive)
Use only the original accessories intended and indicated by
the Manufacturer.
NEBULIZER: For each individual patient, it is recommended to use
the nebulizer for 6 months or up to 120 applications. The nebulizer
shall be replaced after a long period of inactivity, if it is deformed
or broken or if the nozzle is clogged by a dry medicine or medicine
in powder form, etc.
Use the Nosepiece only if prescribed by the doctor. NEVER PUT
the bifurcations into the nose but place them as closely as possible.
Where diseases with risk of infection and microbial contamination are present, it is
recommended to use the accessories and the spray ampoule individually (always seek
medical advice).
The device is equipped with a lter which removes any impurities of the air inhaled from the
compressor. Check the conditions of the lter on a periodical basis or if the device is no
longer efcient. If the lter is too dirty, it shall be replaced.
AIR FILTER REPLACEMENT: The air lter shall be replaced every 25 hours of operation or
when it is too dirty. For the replacement, lift the lter from its seat and replace it with a new one.
The masks and the air hose shall be replaced when there is evidence of deterioration of
their materials.
Expected useful life: More than 1500 operating hours (or 5 years) in accordance with the
standard test and operating conditions. Expected shelf life: up to 5 years from the date of
manufacture.
INSTRUCTIONS FOR USE
• Check the device before each use in order to detect malfunctions and / or damage due to
transport and / or storage.
• When inhaling, the patient must sit upright in a relaxed position at a table and not on an
armchair to avoid compressing the airways and thus compromising the effectiveness of
the treatment.
• It is recommended not hold the device in the hands during the therapy and/or avoid pro-
longed contacts with the casing of the appliance.
WARNING: Place the appliance on at and stable surfaces in order to avoid obstructing the cooling openings located on its sides.
7
6
8
5
4
3
2
1
Page 9
ENGLISH
1. Remove the power cable and insert the plug into the socket, making sure that the power
network corresponds to the data indicated on the appliance plate. It is recommended
to completely unroll the power cable to avoid dangerous overheating. In the event of
damage to the power cable, contact Gima’s technical service for the replacement.
2. Open the nebulizer by unscrewing the cover anticlockwise.
3. Pour the medicine prescribed by your doctor into the nebulizer.
4. Make sure that the nozzle is properly inserted into the air conduction cone located inside
the nebulizer.
5. Close the nebulizer again by screwing the cover clockwise, making sure it is screwed
tight.
6. Connect one air pipe end to the air outlet pipe and the other end to the specic outlet at
the bottom of the nebulizer.
7. Make sure that the air lter is present.
8. Connect the desired accessory to the nebulizer: children or adult mask, mouthpiece or
nosepiece.
9. Set the switch to I and proceed with the atomization.
10. At the end of the atomization, set the switch to O and remove the plug from the socket.
11. Wash the nebulizer and its accessories as specied in the “cleaning” section.
12. Store the accessories into the packaging.
Always use the nebulizer facing upwards in order to prevent any substances and / or the
medicine from leaking out of the nebulizer during normal use.
In the event of overlling, empty the ampoule, clean it and repeat the operation. After having
poured the medicine, screw the top again to the bottom and repeat the operations as specied in section “instructions for use”.
WARNING: The power cable plug is the separation component from the power network;
even though the device has the power on / power off switch, the power plug shall be kept
accessible once the appliance is in use in order to allow an additional method of disconnection from the power network.
NEVER INHALE IN HORIZONTAL POSITION.
DO NOT TILT THE NEBULIZER OVER 60°.
22
ELECTROMAGNETIC INTERFERENCE RISKS AND POTENTIAL CORRECTIVE MEASURES
This section contains information on the device compliance with EN 60601-1-2 (2015). Mistral is a medical device suitable for household use.
Group ranking and CISPR category: group 1, category B
Avoid using this device close to or overlapped on other appliances because it could
not work properly. If such use is necessary and inevitable, special precautions shall be
adopted so that the electromedical device works properly in its standard conguration (for
instance, by steadily and visually checking the absence of anomalies or malfunctions).
The use of accessories, transducers and cables other those supplied by the manu-
Page 10
23
facturer of the appliance may cause an increase in the electromagnetic emissions and/or a
reduction in the electromagnetic immunity of the device, thus causing a malfunction.
Portable and mobile radio communication devices (mobile phones, transceivers, including peripheral devices like antennas cables and external antennas, etc.) may affect the
medical device and should not be used close to (at more than 30cm from any part of the
device, including cables), adjacent to or overlapped on the medical device. If such use is
necessary and inevitable, special precautions shall be adopted so that the electromedical
device works properly in its standard conguration (for instance, by steadily and visually
checking the absence of anomalies or malfunctions).
The tables below provide information on the EMC characteristics (Electromagnetic Compatibility) of this electromedical appliance.
Guide and declaration of the manufacturer – Electromagnetic Emissions
The Mistral aerosol can be used in the following electromagnetic environment. The Customer and/or the user of the Mistral aerosol shall make sure that the appliance is used in
such environment.
Emission test Conformity Guide to the electromagnetic
Radiated emissions /
Conductions CISPR11
Radiated emissions /
Conductions CISPR11
Harmonic currents EN
61000-3-2
Voltage uctuations /
icker EN 61000-3-3
Guide and declaration of the manufacturer – Electromagnetic Immunity
The Mistral aerosol can be used in the following electromagnetic environment. The Customer and/or the user of the Mistral aerosol shall make sure that the appliance is used in
such environment.
Immunity test Standard of proof Level of
Electrostatic
discharge (ESD)
EN 61000-4-2
Fast transient / burst
EN 61000-4-4
Group 1 The Mistral aerosol uses RF energy only for
Class [B] The Mistral aerosol is designed for use in
Class [A]
Compliant
± 8kV contact
± 15kV air
± 2kV power supply
± 1kV signal cables
ENGLISH
environment
Internal function. Therefore, its RF emissions
are very low and do not cause any interference with other nearby electronic appliances.
any environment, including households and
those directly connected to the public power
distribution grid which supplies power to environments intended for domestic use.
conformity
The appliance
does not alter
its status
The appliance
does not alter
its status
Guide to the electromagnetic environment
Floors should be in wood,
cement or ceramics. If oors
are covered by synthetic
material, the relative humidity should be at least 30%.
The power supply should be
that of a typical commercial
premise or hospital.
Page 11
ENGLISH
24
Surge EN 61000-4-5 ± 0.5kV e± 1kV
Voltage dips, short
outages and
voltage variations
EN 61000-4-11
Network frequency
magnetic eld
EN 61000-4-8
differential mode
5% UT (>95% dip
in UT) per 0.5 cycle
40% UT (60% dip
in UT) per 5 cycles
70% UT (30% dip
in UT) per 25 cycles
<5% UT (>95% dip
in UT) per 5 s
30 A/m The appliance
The appliance
does not alter
its status
-- The power supply should be
does not alter
its status
The power supply should be
that of a typical commercial
premise or hospital.
that of a typical commercial
premise or hospital.
If the user of the Mistral aerosol requires the appliance to
work continuously, it is recommended to use it with an
uninterruptible power supply.
The power supply should be
that of a typical commercial
premise or hospital.
Note: UT is the value of the supply voltage
Guide and declaration of the manufacturer – Electromagnetic Immunity
The Mistral aerosol can be used in the following electromagnetic environment. The Customer and/or the user of the Mistral aerosol shall make sure that the appliance is used in
such environment.
Immunity
test
Conducted
immunities
EN 61000-4-6
Radiated
immunity
EN 61000-4-3
Level set out by
EN 60601-1-2
3Vrms 150kHz
to 80MHz
(for non-lifesupporting
appliances)
10 V/m 80MHz
to 2.7GHz
(for non-life-equipment appliances)
Level of
conformity
V
=
1
3 V rms
E
=
1
10 V / m
Electromagnetic Environment Guide
Portable and mobile RF communication
devices should be used no closer than
the separation distance from any part
of the Mistral device, including cables,
calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distances
d= [3.5 / V
d= [12 / E
d= [23 / E
P is the maximum rated output power
of the transmitter in Watt (W) according
to the manufacturer of the transmitter
and d is the recommended separation
distance calculated in meters (m).
The eld strengths from xed RF transmitters, as established in an electromagnetic survey of the sitea, could
be less than the level of conformity of
each frequency rangeb.
] √P
1
] √P 80MHz to 800MHz
1
] √P 800MHz to 2,7GHz
1
Page 12
25
Note 1: At 80 MHz and 800 MHz the highest frequency range applies.
Note 2: These guidelines could not apply to all conditions. The electromagnetic propa-
gation is affected by the absorption and reection of premises, objects and individuals.
a. The eld strengths for xed transmitters like base stations of radiotelephones (mobiles
and cordless) and terrestrial mobile radio networks, amateur radio appliances, AM and FM
radio transmitters and TV transmitters cannot be theoretically and accurately predicted.
In order to determine an electromagnetic environment caused by xed RF transmitters,
an electromagnetic survey of the site should be taken into account. If the eld strength
measured in the place where the Mistral appliance is used exceeds the applicable level
of conformity hereinabove, the normal operation of the appliance should be kept under
watch. If abnormal performances are noted, additional measures could be necessary, such
as a different direction or positioning of the appliance.
b. The eld strength on a frequency range between 150 kHz and 80 MHz should be less
than 10 V/m.
Recommended separation distances between portable and mobile radio communication appliances and the monitor
The Mistral aerosol is designed to operate in an electromagnetic environment in which the
RF radiated interferences are kept under control. The customer or the user of the Mistral
appliance can contribute to prevent electromagnetic interferences by ensuring a minimum
distance between portable and mobile RF communication devices (transmitters) and the
Mistral appliance as recommended below, according to the maximum rated output power
of the radio communication devices.
Maximum rated
output power
of the transmitter
W
Separation distance at transmitter frequency m
150KHz to 80MHz
d= [3.5 / V
1
] √P
ENGLISH
It is possible to check
the interference close
to the appliances labelled
with the following symbol:
80MHz to 800MHz
d= [12 / E
] √P
1
800MHz to 2,7GHz
d= [23 / E
1
] √P
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
The recommended separation distance d in meters (m) for transmitters with maximum
rated output power not specied above can be calculated from the equation applicable
to the frequency of the transmitter, in which P is the maximum rated output power of the
transmitter in Watt (W) according to the manufacturer of the transmitter.
Note 1: At 80 MHz and 800 MHz the separation distance for the highest frequency range
applies.
Note 2: These guidelines could not apply to all conditions. The electromagnetic propagation is affected by the absorption and reection of premises, objects and individuals.
Page 13
SYMBOLS
Caution: read instructions
(warnings) carefully
ENGLISH
26
Follow instructions for use
Keep in a cool, dry place
Manufacturer
Product code Lot number
Medical Device complies
with Directive 93/42/EEC
WEEE disposal
Class II applied Temperature limit
Humidity limit Atmospheric pressure limit
Disposal: The product must not be disposed of along with other domestic waste.
The users must dispose of this equipment by bringing it to a specic recycling point
for electric and electronic equipment.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
Keep away from sunlight
Date of manufacture
Serial number
Type BF applied part
Loading...