PROFESSIONAL MEDICAL PRODUCTS
AEROSOL CORSIA PROFESSIONALE CON MANOMETRO
CORSIA PROFESSIONAL NEBULIZER WITH MANOMETER
NÉBULISEUR PROFESSIONNEL CORSIA AVEC MANOMÈTRE
PROFESSIONELLER CORSIA-INHALATOR MIT MANOMETER
NEBULIZADOR PROFESIONAL CORSIA CON MANÓMETRO
AEROSSOL CORSIA PROFISSIONAL COM MANÓMETRO
AEROSOL PROFESIONAL CORSIA CU MANOMETRU
28105
Gima S.p.A.
M28105-M-Rev.5-09.20
Via Marconi, 1
20060 Gessate (MI) Italy
gima@gimaitaly.com
export@gimaitaly.com
www.gimaitaly.com
Made in Italy
0476
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CORSIA PROFESSIONAL NEBULIZER is a piston-type compressor nebulizer system work-
ing at 230V/50Hz. High performance with any type of drug, ideal for intensive hospital and
clinic use. Manufactured with high thermal and electric insulation plastic chassis in compliance with the latest European Safety regulations. The oil-free piston compressor has long
durability and is equipped with the highly efcient HI-FLO jet nebulizer to guarantee quick
and accurate drug delivery. The medical device is designed for continuous use. The operator
can use the supplied knob to adjust aerosol administration. The device is designed for easy
transport and handling and is recommended for atomising antibiotics and bronchodilator
drugs.
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.
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.
- 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
ENGLISH
safety standards, paying attention not to exceed the maximum power limits indicated
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 Corsia 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. 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.
11. 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.
12. 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.
13. The materials used for the contact with drugs are thermoplastic polymers with high chem-
ical 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
introduce any solution and do not inhale. Contact the technical service, specifying the
methods of use and the type of drug used.
14. Remember to:
- use this appliance only with medicines prescribed by your doctor;
- perform the treatment by using only the accessory instructed by your doctor according
to the disease.
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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.
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PRODUCT SPECIFICATIONS
TYPE (Directive 93/42/EEC) Medical device Class IIa
MODEL Corsia
POWER SUPPLY 230V~ / 50Hz
ABSORBED POWER 170 VA
FUSE F 1 x 1.6A L 250V
MAXIMUM PRESSURE 250 kPa (2.5 Bar)
MAXIMUM FLOW (in the compressor) 16 l/min
OPERATING PRESSURE 130 kPa (1.30 Bar)
OPERATIONAL FLOW 5.2 l/min a 130 kPa
ATOMIZATION 0.50 ml/min (with 4ml solution NaCl 0.9%)
MMAD (measured in accordance
with EN 13544-1)
GSD 3.45
WEIGHT 2.20 Kg
SIZE 255 x 190 x 165 (h) mm
MAXIMUM NOISE LEVEL ~ 57 dB (A)
FUNCTIONING Continuous
MINIMUM NEBULIZER VOLUME LEVEL 2ml
MAXIMUM NEBULIZER VOLUME LEVEL 6ml
OPERATING CONDITIONS Room temperature: 10 ÷ 40°C
STORAGE AND TRANSPORT
CONDITIONS
3.25
Percentage of humidity in the environment:
20 ÷ 85% RH
Atmospheric pressure: 800 ÷ 1060 hPa
Altitude: 0 ÷ 2000m above s.l.
Room temperature: -25 ÷ 70°C
Percentage of humidity in the environment:
10 ÷ 95% RH
Atmospheric pressure: 500 ÷ 1060 hPa
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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 Diam-
eter
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 and no solvents. 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.
MAINTENANCE
The Corsia 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. Before using the device, carry out disinfection as described in
the “CLEANING ACCESSORIES” section. 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 air outlet with one
nger and check the correct functioning of the nebulization regulator by turning the knob from
left to right. Make sure the indicator of the pressure meter is working correctly.
Check that the nebulizer has not suffered any breakage during the previous use (it was
stored inappropriately or has suffered impacts). An easily replaceable protection fuse (F 1 x
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1.6A L 250V) situated in the power plug on the back of the device protects the instrument.
For its replacement, always check the type and the specied range.
Type of defect Cause Corrective action
1. The device
doesn’t work.
2. Poor atomization. Clogged ampoule. Clean and disinfect the ampoule as set
3. Poor atomization. Clogged ampoule. If the washing had no positive outcome,
4. Lack of
atomization.
5. Slow atomization. Excessive oily drug. Dilute the drug with saline.
6. Noisy device. Prolonged use. Contact the reseller or Gima’s technical
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.
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.
The plug may be misplaced in the wall socket.
Thermal protector may be
on (the device has been
working beyond its limits
and / or near heat sources).
Nozzle stuck.
None of the corrective
actions has been effective.
ENGLISH
Make sure the plug is properly placed in
the wall socket. Make sure the ON/OFF
switch is in position I.
Switch off the device by pressing the
switch to position 0 and the motor cool
down for at least 30 minutes.
out in the manual.
replace the ampoule.
Press hard the nozzle (cylindrical im-
mersion tube) placed inside the polycarbonate ampoule bottom with a nger.
service.
Contact the reseller or Gima’s technical
service.
PREPARATION
1. Pull out the air hose from the nebulizer leaving it plugged to the air outlet pipe of the de-
vice.
2. Rotate the upper part of the nebulizer anticlockwise.
3. Disconnect the internal pisper at the bottom of the nebulizer with nger force.
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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 solution 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.
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SUPPLIED ACCESSORIES
ACCESSORIES
HI-FLO accessories kit
(HI-FLO ampoule, Adult Mask, Children Mask,
Air hose, Mouthpiece and Nosepiece)
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)
7
4
6
3
2
5
1
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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. Open the air lter lid from under the bottom, remove the lter and insert the
new one. Place the lid back. Only use original GIMA lters.
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.
WARNING: Place the appliance on at and stable surfaces in order to avoid obstructing the cooling openings located on its sides.
1. Make sure the power cord is thoroughly unrolled to avoid dangerous overheating. In case
the power cord is damaged, contact GIMA technical assistance for replacement.
2. Prepare the HI-FLO nebulizer opening the upper part and pouring the drug prescribed by
your doctor into the lower tank. Close the nebulizer.
3. Connect the air tube into the air outlet placed above the knob of nebulization.
4. Connect the other end of air tube into the bottom of the nebulizer.
5. Connect the selected accessory to the nebulizer: child mask, adult mask, mouthpiece or
nosepiece.
6. Make sure the air lter is placed properly in its seat on the bottom of the device.
7. Press the ON/OFF switch to position I to start nebulization.
8. To interrupt or stop the treatment press again the ON/OFF switch.
9. Adjust the nebulization speedy by turning the knob towards MIN for longer treatments, or
towards MAX for quicker treatments.
ENGLISH
The masks and the air hose shall
ENGLISH
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°.
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ELECTROMAGNETIC INTERFERENCE RISKS AND POTENTIAL CORRECTIVE MEASURES
This section contains information on the device compliance with EN 60601-1-2 (2015). Corsia Nebulizer is a medical device which is particularly useful for intensive hospital and clinic
use.
CISPR classication: group 1, class B. Corsia Nebulizer is an electro-medical device which
requires particular precautions regarding electromagnetic compatibility and which must be
installed and commissioned according to the electro-magnetic compatibility information sup-
plied.
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 manufacturer 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).
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The tables below provide information on the EMC characteristics (Electromagnetic Compatibility) of this electromedical appliance.
Guide and declaration of the manufacturer – Electromagnetic Emissions
The Corsia aerosol can be used in the following electromagnetic environment. The Customer and/or the user of the Corsia 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 Corsia aerosol can be used in the following electromagnetic environment. The Customer and/or the user of the Corsia 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
Surge EN 61000-4-5 ± 0.5kV e± 1kV
Voltage dips, short
outages and
voltage variations
EN 61000-4-11
Group 1 The Corsia aerosol uses RF energy only for
Class [B] The Corsia aerosol is designed for use in
Class [A]
Compliant
± 8kV contact
± 15kV air
± 2kV power supply
± 1kV signal cables
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
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 en-
vironments intended for domestic use.
conformity
The appliance
does not alter
its status
The appliance
does not alter
its status
The appliance
does not alter
its status
-- The power supply should be
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.
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 Corsia aerosol requires the appliance to
work continuously, it is rec-
ommended to use it with an
uninterruptible power supply.
ENGLISH
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Network frequency
magnetic eld
EN 61000-4-8
30 A/m The appliance
does not alter
its status
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 Corsia aerosol can be used in the following electromagnetic environment. The Customer and/or the user of the Corsia 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
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 propaga-
tion is affected by the absorption and reection of premises, objects and individuals.
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
1
V
=
3 V rms
1
E
=
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 Corsia device, including cables, calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distances
1
d= [3.5 / V
] √P
1
d= [12 / E
] √P 80MHz to 800MHz
1
d= [23 / E
] √P 800MHz to 2,7GHz
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.
It is possible to check the
interference close to the
appliances labelled with
the following symbol:
25
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 Corsia 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 Corsia 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 Corsia
appliance can contribute to prevent electromagnetic interferences by ensuring a minimum
distance between portable and mobile RF communication devices (transmitters) and the
Corsia 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
80MHz to 800MHz
1
d= [12 / E
] √P
800MHz to 2,7GHz
1
d= [23 / E
] √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.
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 B applied part
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