MB3 Dosimeter Instruction Manual June 2018

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7KH¿WWLQJIRUFRQQHFWLRQWRWKHPHGLFDOFRPSUHVVHGDLUVVWHPRI 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; b) Connect the PVC 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 operation 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.

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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 as follows: 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 and 3) 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 and 5). 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  (JLIRXZLVKWRFKHFNWKHQXPEHURILQKDODWLRQVLQWKHSURJUDPPHSUHVVNH  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 DATA 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. (J,IRXZLVKWRFKDQJHWKHSDXVHWLPHLQWKHSURJUDPPHSUHVV 15

ENGLISH NHµ3DXVHWLPH¶VRWKDWWKHDFWXDOSDXVHWLPHWREHFKDQJHGLV GLVSODHGWKHQ FDQFHO LW E SUHVVLQJ NH  ³&DQFHO SDXVH WLPH´ 1RZ D QHZ SDXVH WLPH FDQ EH LQWURGXFHG LQWR WKH H[LVWLQJ SURJUDPPH 

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 the diagram. 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 weighs. 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: D $IWHUGLVDVVHPEOLQJIRUFOHDQLQJRU¿OOLQJXSLWLVUHDVVHPEOHG keeping to the parts of the nebulizer with the same numbers and also paying the due attention to their position so that the DUURZVRQWKHQHEXOL]HUDQGRQWKHHOORZEDIÀHDUHDOLJQHG E 7KHFRUUHFWVSHFL¿FGLDJUDPLVXVHGIRUHDFKQHEXOL]HU 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. Example 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; IURPWKHSRLQWZKHUHWKHFXUYHDQGWKHYHUWLFDOOLQHPHHWWUDFH an horizontal axis; WKHSRLQWZKHUHWKLVKRUL]RQWDOD[LVFURVVHVWKHD[LVLQGLFDWHV WKHWLPHQHFHVVDUWRQHEXOL]HWKRVHPJWKDWLVVHFRQG 7KLVVHFRQG RQH LVWKHYDOXHWREHSURJUDPPHGRQWKHNHERDUG RIWKHXQLW

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 16

Take the following equation:

1 : 18.009 = 33 x 10-6 : X

18.009 x 33 X = --------------------- = 0.000594297 grams 1,000,000

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 grams. The percentage of drug to dissolve in one litre of buffer solution is 0.000594297 -----------------0.0075

= 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 0.006 X = --------- = 0.000033316675 = 33.316675 mcmoles 18.009 12 - GENERAL INFORMATION ON THE NEBULIZER, MOUTHPIECE, NOSEPIECE AND NASAL OLIVES The MB2 nebulizer is a medical device WKDW FDQ QHEXOL]H GUXJ LQWR YHU ¿QH 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.

ENGLISH 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. $SSOWKHQRVHSLHFHRUPRXWKSLHFHDQG¿WWLQJDVUHTXLUHG - 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 Thermistor Sensitivity. - 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 ZLOOQRWEHQHEXOL]HGHI¿FLHQWO 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 administered. 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 treatment. Proceed as follows : - Detach the connecting tube from the nebulizer - Remove the mouthpiece or the nasal piece - Remove the thermistor - Unscrew the upper part by turning it anti-clockwise 5HPRYHWKHEDIÀH - 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 heading “Cleaning”. - 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 QHZRQHKDYLQJWKHVDPHFKDUDFWHULVWLFV VHHVSHFL¿FDWLRQV WKHQ 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 &DUEDFKROLQH LV JHQHUDOO SUHSDUHG LQ ÀDFRQV RI  JU DQG LW 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 TROUBLE

PROBABLE CAUSE

REMEDY

• Dosimeter MB3 not operating when switched on

• Plug not firmily in the wall • No power at wall outlet

• Check plug at wall outlet • Check power source,fuse or breaker in house • Replace fuse

• Fuse burnt out • Thermistor not operating

• 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 pneumatic circuit • No power at wall outlet

• Turn thermistor sensitivity dial direction arrow • Check thermistor connection • Change thermistor • Switch on • Push “air tank release” • 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 17

ENGLISH TROUBLE

PROBABLE CAUSE

• The nebulizer will not nebulize

• There is no drug in the • Fill the nebulizer with drug check the baffle nebulizer is inserted in the nebulizer correctly • Tighten all parts • The nebulizer is not assembled properly • The compressor does • Press the compressor switch or the air tank not work release button • Connect the tube • The air tube is not properly to the connected nebulizer and machine • The enter button has • Press enter button not been pressed • The time has not bee • Program the regulated nebulization correctly • The displayed • Make sure that the pressure is not correct pressure is as specified in the instructions manual

• The nebulizer does not work as the manufacturer states

• The nebulizer has not been assembled correctly • The nebulizer has been damaged by oversterilisation • There may be an air leak

REMEDY

• Assemble the nebulizer correctly, keeping to the reference marks. • Change the nebulizer

• Check the compressed air system.

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   7KHGHYLFHPXVWRQOEHXVHGETXDOL¿HGPHGLFDOSHUVRQQHO 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 DQDXWRFODYH¿YHWLPHV 9) It is advisable not to exceed 10 sterilisations in an autoclave. 10) The performance of the nebulizer should be checked using DGHFLPDO¿JXUDHOHFWURQLFEDODQFH0HDVXUHWKHTXDQWLW 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) 18

B) relative humidity 30% to 75% C) atmospheric pressure 700 hpa to 1060 hpa 15) 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 16) 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 17) When replacing plastic paarts such as the nebulizers, used materials must always be disposed of in bins for plastics 18) This device is not protected against the penetration of liquids 19) Never touch the plug or the switch with wet hands 20) 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 21) Never pour liquids onto the equipment when it is on or off 22) Stand the unit on a table or other hard surface during use 23) Do not cover the air grating to prevent overheating 24) The equipment must only be used in rooms where the wiring complies with the latest safety regulations 25) 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 26) Do not switch the equipment if the power cord is damaged 27) Never clean or service the unit when the plug is inserted in the socket 28) The apparatus is not suitable for use in the presence of an anaesthetic mixture with air or oxygen or with nitrous oxide 29) Keep the unit away from sources of heat 30) 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 31) 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 32) 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. SPECIFICATIONS Voltage Absorbed power Power Safety fuse Protection ref. Size (mm) Weight

220-240V ~ 50Hz 1A 240VA F 2,5A – 250V IP40 410 x 410 x 160 h 13 KG

21 - SYMBOLS Operating instructions Warning, read the instructions carefully Serial Number Manufacturer Type BF applied part IP40

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) Keep dry

ENGLISH 22 - SPARE PARTS DESCRIPTION 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 Thermistor

PART NUMBER 471.012 471.007 471.075 471.003 479.005 479.004 479.003 473.038 474.001

TABLE OF CONTENTS General Information

pag. 14

Principle of operation of the DOSIMETER MB3

pag. 14

Physical Inspection of the DOSIMETER MB3

pag. 14

Supplied Accessories

pag. 14

Use of the keyboard

pag. 14

Connection of thermistor and nebulizer to the DOSIMETER MB3

pag. 15

Emergency manual thermistor

pag. 15

Air tank release

pag. 15

Pressure control

pag. 15

Thermistor sensitivity dial

pag. 15

How to programme the DOSIMETER MB3

pag. 15

How to cancel and correct the programmed data

pag. 15

Preparation of the diagram of the MB2 calibrated nebulizer

pag. 16

How to read the diagram of the MB2 calibrated nebulizer

pag. 16

Notes and useful advice

pag. 16

General Information on the nebulizer, mouthpiece, nosepiece and nasal olives

pag. 16

Operation

pag. 17

Inhalation

pag. 17

Cleaning

pag. 17

Disinfecting

pag. 17

Replacement of the fuse

pag. 17

Preparation of Methacoline and Carbacholine

pag. 17

Trouble shooting chart

pag. 17

Warning and Important Notes

pag. 18

Specifications

pag. 18

Spare Parts

pag. 19

Table of Contents

pag. 19

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 Systems S.r.l. 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. 19