MB3 Dosimeter Instruction Manual June 2018.pdf
ITALIANO ............................................................... p.2
FRANÇAIS ............................................................. p.8
ENGLISH .............................................................. p.14
ESPAÑOL ............................................................ p. 20
DEUTSCH ........................................................... p. 26
VLAAMS .............................................................. p. 32
SVENSKA ............................................................ p. 38
NORSK ................................................................ p. 44
DANSK ................................................................ p. 50
PORTUGUÊS ...................................................... p. 56
Medical device for bronchial provocation testing (BPT)
The instructions manual should be thoroughly studied before usLQJWKHHTXLSPHQW
1 - DESCRIPTION OF THE PRODUCT
Bronchial provocation tests (BPTs) are an important diagnostic aid
in the study of bronchial hyper-reactivity states, particularly in determining the etiopathogenesis of asthmatic expressions.
This is an experimental technique that tends to lead to measurable bronchial obstruction in response to the inhalation of various
7KHXVHRI%37VKDVFODUL¿HGWKHLQFLGHQFHRIYDULRXVLPPXQRORJical and other factors in the pathogenesis of asthmatic syndromes
and thus highlighted the existence of various forms of asthma.
An electric signal opens the solenoid valve and allows the air outlet from the nebulizer.
The solution consumption for an established intervention time can
be measured through the nebulizer diagram, depending on the
inhalation time set by the doctor.
3 - PHYSICAL INSPECTION
Each DOSIMETER MB3 is thoroughly tested and carefully packed
at the factory before shipment.
It should be physically free of marks and scratches and in perfect
operating condition upon receipt.
receipt for possible physical damage in transit.
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claim for such damage must be made upon carrier.
4 - SUPPLIED ACCESSORIES
Each Dosimeter MB3 is supplied with the following items:
$VWXG\RIWKHHIIHFWVRISKDUPDFRORJLFDODJHQWVDQGVSHFL¿FLPmunotherapy in asthmatics examined using this method has led to
a more rational therapeutic protocol for these patients.
BPTs allow experimental reproduction of bronchospastic reactions, and a more accurate analysis of the progression of the crisis
and the pharmacological effect of prevention or resolution. (D’Amato: Allergia respiratoria da pollini e da miceti).
A simple easy-to-use instrument that makes it possible to show the
reactivity threshold due to the dose of a known quantity of inhaled drug
and to standardise factors affecting the dosage is the MB3 Dosimeter.
The Dosimeter MB3 supplies an unique instrument :
• For bronchoprovocation tests: Allergology - Pneumology - Epidemiology - Preventive Medicine
• For nasal provocation tests: Ear nose and throat
therefore good interpolmonary distribution of the particles: Nuclear Medicine
The bronchial provocation test is only performed by properly qualL¿HGGRFWRUVZKRWDNHIXOOUHVSRQVLELOLW\IRUXVHRIWKHGHYLFHDQG
With 25 years’ experience with the Dosimeter and the co-operation of numerous doctors, Air Liquide Medical Systems S.r.l. has
gradually been able to perfect the product.
conjunction with research and development in developing new
products. And continuous development is the key word at Air Liquide Medical Systems S.r.l. - full compliance with various technical standards, a quality system with permanent monitoring of the
entire production process, product traceability, risk analysis, studies on the biocompatibility of materials and regular attendance at
all more important Congresses and trade fairs.
2 - PRINCIPLE OF OPERATION OF THE DOSIMETER MB3
nebulizer with the necessary quantity, the doctor has to instruct the
patient through the test.
The circuit activation is automatically initiated by patient inspiration
through the nebulizer or alternatively by an operator-controlled
electronic trigger (emergency manual thermistor).
TRANSPARENT NON-TOXIC PVC TUBING
SMALL SIZE NOSE OLIVES
MEDIUM SIZE NOSE OLIVES
LARGE SIZE NOSE OLIVES
5 - USE OF THE KEYBOARD
General on / off switch
Control keys to set programme from 0 to 9
Thermistor connection socket
Recalls on display the inhalation time
Cancels inhalation time so that new time may be
Recalls the pause time between each inhalation
Cancels pause time so that new pause time may be
Recalls the total number of inhalations programmed
Cancels number of inhalations so that new number
may be imposed
Indicates the part of the programme in course
Key to empty the air tank
Thermistor sensitivity regulator
On / off switch for compressors only.
Manometer to note the pressure during the test
the hospital is situated on the rear panel.
6 - PREPARATION OF THE INSTRUMENT
CONNECTION OF THERMISTOR AND MB2 NEBULIZER TO
THE DOSIMETER MB3
a) Connect the thermistor to
the “T” piece of the nebulizer
and the metal plug at the end
of the cable to the “Thermistor
Connector” socket of the unit;
transparent tubing to the
nebulizer nipple at one end
and to the “Air Socket” of the
unit at the other end.
Dosimeter MB3 operates in two ways:
- by connecting to the compressed air supply system, which must
supply at 3-5 bar;
- with the aid of the internal compressor, which allows autonomous
CONNECTING THE DOSIMETER MB3 TO AN EXTERNAL
MEDICAL COMPRESSED AIR SUPPLY
The point of connection to the
medical compressed air supply is
located on the rear panel of the
device, just above the power socket.
Screw in the connecting pipe to
the medical compressed air intake
sleeve as shown in the figure below.
EMERGENCY MANUAL THERMISTOR
In case that the automatic thermistor functioning by patient’s inhaling
is defected, use the EMERGENCY MANUAL THERMISTOR.
In this case synchronization between inhalation and the start of
nebulization is controlled by the doctor, who tells the patient to
breathe in and presses the button at the same time.
AIR TANK RELEASE
Before starting the testing, press several times “AIR TANK RELEASE” in order to wet well the internal part of the nebulizer.
PRESSURE CONTROL FROM THE MANOMETER
During the inhalation operation, the value of pressure should be of
atm.1,8 ±0,10 atm., corresponding to bar 1,8 ±0,10 bars, which
correspond to psi 25,6 ±1,4 psi.
1 bar = 1 atm=1Kg/cm2
BRITISH PRESSURE UNIT POUND FOR SQUARE INCH : 1 bar
= 14,22 p.s.i.
THERMISTOR SENSITIVITY DIAL
The Thermistor sensitivity dial must be regulated according to the
inhalatory capacity of the patient (High values correspond to a
high thermistor sensitivity due to a low inhalatory capacity of the
patient; low values correspond to low thermistor sensitivity due to
a high inhalatory capacity of the patient).
Before connecting the thermistor to the DOSIMETER MB3, turn the
thermistor sensitivity regulator (15) counterclockwise to the end.
In the case it does not move, it should be unblocked: simply move
the black stop lever behind the knob.
The thermistor sensitivity dial should then be regulated by turning
the knob in the direction of the arrow, until it is automatically activated by the patient when inhaling. The sensitivity of the thermistor sensitivity dial could reach the point of automatic start of the
thermistor and the automatic functioning of MB3 (without patient
actioning it by inhaling).
7 - HOW TO PROGRAMME THE DOSIMETER MB3
When the DOSIMETER MB3 is switched on, the display and the
inhalation time led are illuminated. The unit must be programmed
a) Set the INHALATION TIME for each inhalation.
Max. length of time: 9,9 sec.
(Eg. : If the requested aerosol delivery time is 1,3” press keys 1
b) Set the PAUSE TIME between two inhalations.
Max. length of pause time : 99,9 sec.
(Eg.: If the requested pause time is 6,5” press keys : 0, 6 and 5).
It is advisable to keep a minimum pause time of at least 3 seconds between one inhalation and the next one.
c) Set the total NUMBER OF INHALATIONS.
Max number of inhalations : 99.
(Eg. : If the requested number of inhalations is 5, press keys: 0
d) Once the programme has been set, press ENTER (3) to activate the thermistor.
Keys 5, 7 and 9 serve to check the readings programmed
If you need to switch the unit off without cancelling the data previously programmed, switch off the compressor only (“compressor
only on/off switch” on the front panel).
8 - HOW TO CANCEL AND CORRECT THE PROGRAMMED
Keys 6 “CANCEL INHALATION TIME”, 8 “CANCEL PAUSE TIME”
and 10 “CANCEL INHALATION NUMBER” cancel each of the programmed readings allowing new data to be inserted.
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micrograms (mcg) or moles.
So, mg (milligram) is one thousandth of a gram
mcg ( microgram) is one millionth of a gram
mole is the atomic weight of the elements comprising the solution
9 - CALIBRATED NEBULIZERS CONSUMPTION DIAGRAM
Both upper and lower part of every nebulizer supplied with the
DOSIMETER MB3 is numbered.
After cleaning and reassembling, according to the positions indicated by the arrows, a quantity of 3 ml of saline solution is introduced.
7KUHHZHLJKLQJVDUHWKHQHIIHFWHGWKH¿UVWRIZKLFKDIWHUDQHEXOLzation time of 0,5 seconds, the second after 1 second and the third
after 1,5 seconds of nebulization.
Every measurement is repeated four times and the arithmetic
mean of the results of these four measurements is indicated on
All these details transferred on the diagram forms a curve which
indicates what is the nebulization time to be programmed, once
the quantity of buffer solution to be nebulized is known. Each diagram is numbered with the same number of the nebulizer it refers
to: each nebulizer has its own diagram which cannot be used for
any other nebulizer, as it would not be valid.
Here is an example regarding the mole.
If we take distilled water, the chemical formula of which is H2O,
we can calculate how many grams one molecule of distilled water
Atomic weight of hydrogen (H) = 1.007
Atomic weight of oxygen (O) = 15.995
Total atomic weight of distilled water =
1.007 + 1.007 + 15.995 = 18.009
So one mole of distilled water weighs 18.009 grams.
Here are some sample conversions.
If we have to administer 33 mcmoles of drug, how many grams
does that correspond to?
Each nebulizer repeats its own results on condition that:
keeping to the parts of the nebulizer with the same numbers
and also paying the due attention to their position so that the
c) Pressure values shown by the manometer are correct when operating;
d) The environmental conditions (temperature and humidity) are
not modifying the nebulization diagram.
Now we can determine how much drug is nebulized. But remember that a puff only partially contains nebulized drug depending on
the percentage of it dissolved in the buffer solution.
10 - HOW TO READ THE CONSUMPTION DIAGRAM
The diagram shows the quantity in milligrams of the solution nebulized from 0 to 1,5 seconds.
The nebulized quantities expressed in milligrams are represented
on the X-axis, whilst the nebulization time expressed in seconds is
shown on the Y-axis.
For the administration of 9 mg of solution please proceed as folORZV
- locate the value of “9” on the x-axis and trace a vertical line from
this point until the characteristic curve is met;
an horizontal axis;
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11 - NOTES AND USEFUL ADVICE
When preparing the solution to inhale, the problem is knowing how
much drug is nebulized and the percentage of drug and buffer
solution to prepare.
First of all, remember that the unit of measurement with the Dosimeter is the milligram (mg) whereas drug dosages are expressed in
Take the following equation:
1 : 18.009 = 33 x 10-6 : X
18.009 x 33
X = --------------------- = 0.000594297 grams
How to prepare the solution.
If we have to administer 33 mcmoles of drug, what is the percentage in one litre of buffer solution?
First of all we need to know how much drug is nebulized. So take
one of the nebulizers that come with the MB3 Dosimeter and read
the accompanying graph. Be careful not to get it muddled up with
the graphs of the other nebulizers. Let us suppose that the sample graph taken shows a nebulization of 7.5 mg (0.0075 grams) for
an inhalation time of one second.
We have already seen that 33 mcmole corresponds to 0.000594297
The percentage of drug to dissolve in one litre of buffer solution is
= 0.0792396, rounded up to 0.08, so equal to 8%
We can work backwards as a check.
8% of 7.5 mg is 0.6 mg, which is the quantity of drug present in a
one-second puff using the nebulizer delivering 7.5 mg.
We can convert the 0.6 mg into moles using the simple equation
1 : 18.009 = X : 0.006
X = --------- = 0.000033316675 = 33.316675 mcmoles
12 - GENERAL INFORMATION ON
NOSEPIECE AND NASAL OLIVES
The MB2 nebulizer is a medical device
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particles size 1.4 - 1.7 MMAD*
Use the mouthpiece or nosepiece,
depending on the test to carry out.
The nasal olives must be used with the
nosepiece to ensure a perfect seal in the nostrils.
* MMAD = Median Mass Aerodynamic Diameter, the unit of
measurement for particles.
13 - OPERATION
First clean and sterilise the nebulizer.
Then check that the ambient temperature is the
same as the value shown on the graph ±1°C.
After programming the instrument following the
instructions under “How to Program the MB3
Dosimeter”, proceed as follows.
- Make sure the nebulizer is clean after the previous session.
- Pour the drug in from the top or unscrew
the nebulizer anticlockwise and pour the drug
straight in. Then screw the two parts together
as shown by the arrows.
- Hold the nebulizer upright.
- Fit the connecting tube onto the air intake on the Dosimeter.
- Connect the thermistor.
- If the appliance is designed for connection to the compressed
air mains, activate the green illuminated switch marked ON/OFF
Unit (Ref. 1).
If you wish the appliance to operate independently, make sure it
is not connected to an external supply in order to prevent stress.
Then activate the green illuminated switch market “ON/OFF Unit”
(Ref. 1) and the black switch marked “ON/OFF for compressor
only” (Ref. 16).
- Regulate the thermistor following the instructions under Adjusting
- Press the Air Tank Release button for 2 - 3 seconds to wet the
walls of the nebulizer.
- Check that everything is connected properly, otherwise the drug
14 - INHALATION
Sit on a chair in an erect, relaxed position.
Place the mouthpiece between the lips and breathe deeply.
An acoustic signal will sound while the drug is being administered.
It will continue for the set time and then the drug will stop being
The mouthpiece must be removed as the subject breathes out.
15 - CLEANING
After each treatment a small amount of
medicine remains in the nebulizer. This
contaminates the next treatment. To exclude any danger of infection through
contamination, all components used
must be thoroughly cleaned after each
Proceed as follows :
- Detach the connecting tube from the
- Remove the mouthpiece or the nasal
- Remove the thermistor
- Unscrew the upper part by turning it anti-clockwise
- Wash all the nebulizer components in hot water and a little detergent
- Rinse under running water and allow to drip
- Dry all the components with a clean cloth
- After drying, reassemble the components.
If a small amount of humidity remains in the air tube after each
treatment, the nebulizer should be removed and the dosimeter left
on to allow the ventilation from the compressor to dry the tube.
121 °C for 15 to 30 minutes. Please place the single components of
the nebulizer in the autoclave machine as indicated in the drawing.
- Allow the nebulizer components to cool.
- Dry thoroughly as described under
- After drying, reassemble the components.
17 - REPLACEMENT OF THE FUSE
To replace the fuse proceed as follows:
Having disconnected the plug from the wall socket, remove the
fuse-holder located on the back side of the equipment, near to the
socket, using a screw-driver (not supplied with the unit).
Take out and throw away the old safety fuse and replace it with a
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place the fuse-holder back into its seat.
PREPARATION OF METHACOLINE AND CARBACHOLINE AS
USED IN PROF. MELILLO’S DEPARTMENT AT CARDARELLI
HOSPITAL OF NAPLES
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is then diluted by preparing different solutions (eg. 20 ml of Carbacholine at 5% pH 5,81 plus tampon solution).
It can thus be used with the Dosimeter in the same way as Methacoline.
As for Methacoline, the following protocol is used in Prof. Mellilo’s
department at the CARDARELLI HOSPITAL of Naples.
Methacoline 5% (50 mg/ml) is obtained by diluting 5 gr of Methacoline in powder, in 100 ml of distilled water.
For the inhalation, 20 ml of Methacoline at 5% is used (pH 4,48)
plus 47 ml of solution “A” (*) plus 34 ml of solution “B” (*) (= 100 ml
of Methacoline 0,1% at pH 7).
It is necessary to follow a correct progression with the doses which
also depends on the calibration of the nebulizers.
It is also necessary to remember that the dose is accumulative.
(*) = Solution “A” comes from 8,9 gr of phosphatodisodic plus 500
ml of distilled water.
Solution “B” comes from 6,9 gr of phosphatodisodic plus 500 ml
of distilled water.
18 - TROUBLE SHOOTING CHART
• Plug not firmily in the
• No power at wall
• Check plug at wall
• Check power
source,fuse or breaker
• Replace fuse
• Fuse burnt out
• Sensitivity dial turned
all way left
• Thermistor not
plugged in well
• Defected thermistor
• Compressor • Compressor or unit
does not start switched off
• Pressure in the
• No power at wall
• Turn thermistor
sensitivity dial direction
• Check thermistor
• Change thermistor
• Switch on
• Push “air tank
• Check power spurce
16 - DISINFECTING
Only one patient should use the nebulizer, unless it has been previously sterilised or disinfected.
To reduce the danger of infection proceed as follows:
- clean all nebulizer components as described above.
- disinfect or sterilise all nebulizer components in an autoclave at
• There is no drug in the • Fill the nebulizer with
drug check the baffle
is inserted in the
• Tighten all parts
• The nebulizer is not
• The compressor does • Press the compressor
switch or the air tank
• Connect the tube
• The air tube is not
properly to the
nebulizer and machine
• The enter button has • Press enter button
not been pressed
• The time has not bee • Program the
• The displayed
• Make sure that the
pressure is not correct
pressure is as specified
in the instructions
work as the
• The nebulizer has
not been assembled
• The nebulizer has
been damaged by
• There may be an air
• Assemble the
keeping to the
• Change the nebulizer
• Check the
If the problem persists after you have made these checks, send
the dosimeter to an authorized centre for repair.
19 - WARNINGS AND IMPORTANT NOTES
1) The dosimeter MB3 must only be used for bronchial provocation tests (bpt). It is not approved for any other applications
3) The substances used for the tests must be selected by a doctor specialised in bronchial provocation tests
4) The doses administered must be determined by the doctor
supervising use of the dosimeter
5) It is advisable to have a bronchodilator available during the
test in case the subject should suffer a bronchorestriction crisis due to administration of the wrong dosage.
6) Do not use medicated solutions containing essential oils (i.e.
eucalyptus and menthol), aldehydes or phosphates due to
chemical and physical incompatibility with the material that the
nebulizer and accessories are made of
7) The nebulizer must only be used for bronchial provocation
tests (BPTS). It is not approved for any other applications
8) The nebulizer should be checked after it has been sterilised in
9) It is advisable not to exceed 10 sterilisations in an autoclave.
10) The performance of the nebulizer should be checked using
nebulized in one second using 3 ml physiological solution.
Make sure the value is the same as shown on the graph. The
tolerance range is +/- 1 mg
11) The nebulizer is guaranteed to nebulize drug correctly at the
ideal particle size for the correct length of time provided that
the instructions are followed carefully.
12) This device is designed for continuous operation
13) For safety reasons, the nebulizers and its components must
be replaced with original spares only
14) Environmental conditions for use must be:
A) ambient temperature for drug administration (see nebulizer
graph, tolerance ±1°c)
B) relative humidity 30% to 75%
C) atmospheric pressure 700 hpa to 1060 hpa
Environmental conditions for storage must be:
A) ambient temperature from -25°c to +50°c
B) relative humidity 30% to 95%
C) atmospheric pressure 700hpa to 1060hpa
Be very careful with the compressed air generated by the unit.
It can be a source of danger if the unit is not used by authorized personnel
When replacing plastic paarts such as the nebulizers, used
materials must always be disposed of in bins for plastics
This device is not protected against the penetration of liquids
Never touch the plug or the switch with wet hands
Should the unit fall into water or any other liquid, disconnect
the plug from the wall socket beefore touching the unit. Do not
use it - send it to an authorized centre
Never pour liquids onto the equipment when it is on or off
Stand the unit on a table or other hard surface during use
Do not cover the air grating to prevent overheating
The equipment must only be used in rooms where the wiring
complies with the latest safety regulations
Before inserting the plug into the mains socket, make sure
that the mains voltage corresponds to the voltage indicated
on the label on the back side of the unit
Do not switch the equipment if the power cord is damaged
Never clean or service the unit when the plug is inserted in the
The apparatus is not suitable for use in the presence of an
anaesthetic mixture with air or oxygen or with nitrous oxide
Keep the unit away from sources of heat
The manufacturer is liable for the safety, reliability and good
performance of the equipment, provided that any repairs are
effected only by an authorized centre
The manufacturer is liable for the safety, reliability and good
performance of the equipment, provided that it is used according to the instructions for use
If the user does not comply with these important notes and
instructions for use, the manufacturer cannot be held liable
and the warranty does not apply
20 - SPECIFICATIONS
The compressor requires no lubrication.
220-240V ~ 50Hz
F 2,5A – 250V
410 x 410 x 160 h
21 - SYMBOLS
Warning, read the instructions carefully
Type BF applied part
Device protected against access by wires and non
protected against access by liquids
Product to be disposed of by separate collection at
the end of its life cycle; do not dispose of as unsorted
municipal waste (European Directive 2002/96/EC)
22 - SPARE PARTS
Set ot five tested nebulizers
Mouth piece (one)
Nose pieces (one)
“T” connector (one)
Set of two large size nose olives
Set of two medium size nose olives
Set of two small size nose olives
Transparent pvc tubing
TABLE OF CONTENTS
Principle of operation of the DOSIMETER MB3
Physical Inspection of the DOSIMETER MB3
Use of the keyboard
Connection of thermistor and nebulizer to the
Emergency manual thermistor
Air tank release
Thermistor sensitivity dial
How to programme the DOSIMETER MB3
How to cancel and correct the programmed data
Preparation of the diagram of the MB2 calibrated
How to read the diagram of the MB2 calibrated
Notes and useful advice
General Information on the nebulizer, mouthpiece,
nosepiece and nasal olives
Replacement of the fuse
Preparation of Methacoline and Carbacholine
Trouble shooting chart
Warning and Important Notes
Table of Contents
Air Liquide Medical Systems S.r.l.
All rights reserved. The informaion contained in the present publication may not be used for reasons other than those for which it
was originally intended. No part of this publication may be reproduced without the prior permission in writing of Air Liquide Medical
In order to maintain and improve production standards, operating
capacity and increase reliability, Air Liquide Medical Systems S.r.l.
appliances are periodically reviewed. For this reason the contents
of this publication are subject to changes withour prior notice. The
updated version of the present document, should it become outdated, can be had on request from the local distributor or agent for
the zone by specifying the edition in your possession.
Cod. 811051 Rev. 06/2018
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N° de série do aparelho
DOS C/E …………………………/…………………
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The apparatus described herein was designed and built by:
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Das in der vorliegenden Veröffentlichung beschriebene Gerät ist ein Produkt der Firma:
Het in deze uitgave beschreven apparaat is ontworpen en gefabriceerd door:
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Air Liquide Medical Systems S.r.l.
Via dei Prati, 62 - 25073 Bovezzo (BS) ITALY
Tel. (+39) 030.201.59.11 - Fax (+39) 030.2098329