Medel Pro User manual

ISTRUZIONI PER L’USO / INSTRUCTION MANUAL
MEDEL PRO - feb. 2006 - COD. 14253
SISTEMA PER
AEROSOLTERAPIA
AD ARIA COMPRESSA
COMPRESSOR
NEBULIZER SYSTEM
PRO
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9
10
13
14
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3
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6
Fig. A
Fig. B Fig. C
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Fig. D Fig. G
Fig. E Fig. H
Fig. F Fig. I
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MEDEL PRO
Sistema per aerosolterapia ad aria compressa
Manuale di istruzioni
INDICE/INDEX
I3
UK 11
F19
D27
P35
N43
TR 51
NL 59
PL 67
KSA 75
E91
ATTENZIONE:
Togliere l’apparecchio dalla borsa prima dell’uso!
WARNING:
Remove the compressor from carrying case before use!
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MEDEL PRO COMPONENTS (PIC. A)
1. Main unit
2. ON/OFF switch
3. Power cord
4. Air outlet
5. Filter holder
6. Nebulizer holder
7. Air vent openings
8. Handle
STANDARD ACCESSORIES
9. MEDELJET PRO nebulizer
10. Mouthpiece
11. Nosepiece
12. Air tube
13. Adult mask
14. Pediatric mask
15. Carrying case
IMPORTANT:
Read these instructions carefully before using this device.
GENERAL INFORMATION
MEDEL PRO is a compressor nebulizer system for aerosol therapy for intensive use.
MEDEL PRO is supplied with the MEDELJET PRO nebulizer, a new and patented exhalation/inha-
lation valves system, which increases the amount of inhaled medication, minimizing the medica-
tion waste.
EXCLUSIVE DOUBLE-VALVE SYSTEM OPERATING DETAIL
Illustration B
During inhalation phase, the inhalation valve (pic. B/16) opens, automatically-operated by
patient’s breath, thereby allowing an additional air flow (pic. B/17) to the compressor-generated
one (pic. B/18), therefore increasing the nebulization of medication and the medication quantity
effectively inhaled.
Illustration C
During exhalation phase, the inhalation valve (pic. B/16) closes avoiding medication to be disper-
sed in the environment while the exhalation valve (pic. C/19) opens thereby allowing the exha-
lation.
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PRECAUTIONS
1. Only use the device for its intended purpose as described in this instruc-
tion manual, therefore as a compressor nebulizer system for aerosolthe-
rapy, following the indications of your doctor. Any other form of use constitutes
an improper use and is therefore dangerous. The manufacturer cannot be held liable for
any damage caused by improper, incorrect or unreasonable use, or if the unit is connected
to electrical installations which do not conform with safety regulations.
2. Keep this manual for future reference.
3. Do not operate the unit in presence of any anesthetic, inflammable mixtures, oxygen or
nitrogen monoxide.
4. The correct device functioning can be affected by electromagnetic interference which
exceeds the limits indicated by the European standards in force. In case this device interfe-
res with other electrical apparatus, remove it and plug it to a different socket.
5. In case of failure and/or malfunction, read the ”POSSIBLE PROBLEMS AND HOW TO
SOLVE THEM” section. Do not handle nor open the compressor housing.
6.
Any repairs must be carried out by an authorized dealer using only original spare parts.
Safety of the device can be compromised in case the above mentioned indications are not met.
7. When using any electrical appliance certain important safety measures must always be
observed, including the following:
- use only original accessories and components;
- never submerge the unit in water;
- the device is not protected against water penetration;
- never touch the unit when your hands are wet or moist;
- do not leave the unit outdoor;
- the unit, when operating, must be placed on a stable and horizontal surface;
- make sure the air vent openings are not obstructed (pic. A/7);
- do not allow unsupervised children or infirm persons to use the unit;
- do not disconnect the unit by simply pulling out the plug from the wall socket.
8. Make sure that the electrical rating shown on the rating plate on the bottom of the unit cor-
responds to your main voltage and frequency before plugging in the device.
9. If the power plug provided with the device does not fit your wall socket, have the plug chan-
ged by an electrical appliance dealer. Do not use any adapter, simple or multiple, and/or
extension cable. In case their use is necessary, make sure they are in compliance with safety
standards, paying attention they do not exceed the maximum load.
10. Do not leave the unit plugged when not in use: unplug the device from the wall socket when
not operating.
11.
Follow the manufacturer’s instructions for installing the device. The manufacturer cannot be held
responsible for any damage caused to persons, animals or things by incorrect installation.
12. The power supply cord cannot be replaced by the user. In case the power supply cord beco-
mes damaged, address to the technical servicing authorized by the manufacturer for repla-
cement.
13. The power supply cord should always be fully unwound in order to prevent dangerous
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overheating.
14. Before performing any maintenance or cleaning operation, disconnect the device from the
main supply, by unplugging it or by turning the main supply switch off.
15. Some parts of the unit are so small that they could be swallowed by children; do not let unat-
tended children have access to the unit.
16. If you decide not to use the device any longer, it is recommended to dispose of it according
to the regulations in force.
17. Remember to:
- use this device only with medications prescribed by your doctor;
- make the treatment only using the accessory recommended by your doctor for the therapy;
- use the “nose piece” accessory only if expressly indicated by your doctor and paying
attention NEVER to introduce inside the nose the nasal bifurcation, but only bring it as close
as possible.
18. Verify that the medications prescribed by your doctor can be used with common compres-
sor nebulizer systems for aerosoltherapy.
DEVICE SAFETY SYSTEMS
THERMAL PROTECTOR
The inhalation device is provided with a temperature protection device which is released when the
device is overheating switching the unit off.
INSTRUCTIONS FOR USE
Remove the compressor from carrying case before use.
Check the unit before each use, in order to check for possible function anomalies and/or dama-
ges due to transport and/or storage.
When inhaling, sit upright and relaxed at a table and not in armchair as otherwise you will con-
strict your respiratory passages and impair the effect of inhalation.
1. As soon as you have unpacked the device, check it for visible damages or defects. In par-
ticular, check for cracks in the plastic housing, which could expose electrical components.
2. Check for accessories integrity.
3. Before using the device, proceed with the cleaning operations as described in the
“CLEANING AND DISINFECTION” section.
4. Open the nebulizer (pic. A/9) by turning the top in an anticlockwise direction (pic. D). On
the top an arrow, together with “CLOSE” sign, suggest how to close the nebulizer
5. Make sure the water conduction cone is properly fitted onto the air conduction cone inside
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the nebulizer (pic. E).
6. Put the prescribed medication dose into the nebulizer (pic. F). The graduated scale can be
useful to control the correct medication quantity.
7. Close the nebulizer by turning the two parts in a clockwise direction, paying attention that
they are thoroughly sealed.
8. Connect one end of the air tube to the nebulizer (pic. G) and the other end to the air outlet
on the device (pic. A/4).
9. Use the MEDELJET PRO nebulizer with inhalation valve only with mouthpiece having exha-
lation valve. When using the masks or the nosepiece, it is not necessary to keep inhalation
valve: remove it (pic. B/16) and connect the nosepiece or the masks directly onto the nebu-
lizer (pic. I).
10. Plug the device to the wall socket, making sure that the electrical rating shown on the rating
plate on the bottom of the unit corresponds to your main voltage.
11. To start the treatment, switch the device on by pressing the switch (pic. A/2) in the front of
the device onto the “I” position.
12. Inhale the aerosol solution using the prescribed accessory.
13. When the treatment has been completed, switch the unit off by setting the switch position
“O” and disconnect the plug from the wall socket.
14. Wash the nebulizer and accessories as described in the “CLEANING AND DISINFECTION
OF THE ACCESSORIES” section.
15. Put the nebulizer, accessories and power cord inside the carrying case (pic. A/15).
CLEANING AND MAINTENANCE
CLEANING OF THE MAIN UNIT
Use a clean dry cloth and mild detergents for cleaning the unit.
ATTENTION: during cleaning operations, make sure liquids do not get
inside the device.
CLEANING AND DISINFECTION OF THE ACCESSORIES
After each treatment:
The nebulizer MEDELJETPRO, the mouthpiece and the nosepiece must be disinfected by boiling in
water (for max. 10 minutes) or in autoclave (max 121°C, see autoclave instructions for duration).
We suggest you disinfect the masks using cold disinfecting liquids (solutions with hypochlorite).
Dry the nebulizer using a clean cloth; after connect it to the air outlet (pic. A/4), switch the devi-
ce on and let it work freely for 5-10 minutes.
Do not boil nor autoclave the air tube and the masks.
Following carefully the cleaning and disinfecting instructions is very
important for the product performance and for a successful therapy.
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REPLACEMENT OF THE NEBULIZER
The nebulizer must be replaced after a long period of inactivity, or when it is obstructed by dry
medication, dust, etc.
Your nebulizer should last from 6 months to 1 year with general use.
Use original nebulizers only.
REPLACEMENT OF THE FILTER
The MEDEL PRO Porex filter must be replaced approximately after 500 hours of use or each year;
control the filter periodically (10-12 aerosol treatments ); when it turns grey or brown or wet,
replace it; open the filter holder (pic. A/5) and replace the filter with a new one. Don’t try to clean
the filter and to reuse.
Use original filters only.
Do not use the unit without filter.
POSSIBLE PROBLEMS AND HOW TO SOLVE THEM
If the device does not switch on:
1. make sure the plug is firmly fitted to the wall socket;
2. the thermal protector might have been released. The thermal protector may be released for
the following reasons:
- the device has been in operation for a too long time;
- the device was used near heaters or in hot environments;
- the air vent openings (pic. A/7) are obstructed and do not allow for the motor ventilation.
In this case, set the ON/OFF switch to “O” and let it rest for at least 60 minutes.
If the device does not nebulize, or only very weakly, check the following
points:
1. make sure that the ends of the air tube are fitted tightly onto the main unit and onto the
nebulizer;
2. check whether the nebulizer is empty from medication or full of an excessive medication
quantity (MAX 15 ml);
3. check whether the nebulizer nozzle is obstructed;
4. check whether the air conduction cone is inserted (pic. E).
Should the device not start working properly again, address immediately to
an authorized technical service centre or to MEDEL CUSTOMER SERVICE.
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MAINTENANCE AND REPAIRS
In case of failure, address to qualified personnel authorized by Medel S.p.A.. Never open the
device. There are no user-serviceable parts within. The compressor requires no lubrication or
maintenance.
TECHNICAL SPECIFICATIONS
Model: MEDEL PRO
Electricity supply: see rating label on the device bottom
Nebulizer air flow: 3,3 l/min
Compressor air flow: 7,50 l/min
Compressor max. pressure: 250 kPa (2,50 bar)
Weight: 1,91 kg
Size: (H) 106 x (L) 198 x (P) 233 mm
Noise Level: 52 dBA
Nebulization rate: ca. 0,5 ml/min
Particle size: MMAD 1,8 µm (NaCl) – API AEROSIZER;
MMD 4,17 µm – INSITEC MALVERN
MEDELJET PRO
nebulizer capacity: 15 ml (MAX)
Class II Device (Double Safety Insulation)
Type B Device (device with specific protection against electrical hazards)
Device for continuous use.
Device not protected against sprinkles
Device not suitable for use in presence of anaesthetic substances inflammable with air, oxygen or
nitrogen protoxide.
Device not suitable for use in anaesthesia or pulmonary ventilation systems.
Technical modifications reserved!
Reference to Standards: Electric Safety Standards CEI EN 60601-1
Electromagnetic Compatibility according to CEI EN 60601-1-2
Class II Medical Device according to 93/42/EEC
“Medical Device” Directive.
AMBIENT CONDITIONS
Storing Conditions
Temperature: MIN -25°C - MAX 70°C
Humidity: MIN 10%RH - MAX 95%RH
Operating Conditions
Temperature: MIN 10°C - MAX 40°C
Humidity: MIN 10%RH - MAX 95%RH
Altitude: from 0 to 2000m above sea level
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DEVICE SYMBOLS
ION
OOFF ~Alternating Current
Type B Class II
Separate collection
ATTENTION: Read carefully the instructions
According to 93/42/EEC Directive.
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WARRANTY CERTIFICATE
Warranty conditions
-
The device is covered by a 5-year warranty from date of purchase for any defects in the design
or in the materials used.
- The warranty consists in the replacement and/or repair free of charge of originally defective
components.
- The warranty does not cover the accessories supplied with the device and those parts subject
to normal wear and tear.
- The device must be repaired by authorized technical service centres only.
- The device must be sent to the authorized service centre for repair within 8 days after the defect
is noticed.
- The transport costs for the device are at user’s charge.
- Any repair out of the warranty conditions are at user’s charge.
- The warranty does not cover failures resulting from misuse, abuse of the product or in case the
damage is not due to manufacturer’s liability (accidental fall, rough transportation, etc.).
- The warranty does not involve any compensation for any kind of damages to persons or things,
either direct or indirect, occurred when the device is not operating.
- The warranty is valid from the date of purchase certified by the ticket or the invoice which have
to be peremptorily attached to the warranty coupon.
- The lack of warranty coupon properly filled in and validated by a certification of purchase
voids the warranty.
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COUPON TO BE RETURNED IN CASE OF REPAIRS
THE WARRANTY IS VALID ONLY IF ACCOMPANIED BY
THE TICKET/INVOICE
Product type:
Model:
Serial No.:
Date of purchase:
BUYER DATA:
Name:
Address:
Phone number:
Defect description:
Signature for acceptance of the above mentioned warranty conditions
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MEDEL PRO - feb. 2006 - COD. 14253
Questo dispositivo è conforme alle disposizioni
della Direttiva Comunitaria Europea 93/42/CEE.
This device fulfils the provisions of the EC Directive 93/42/EEC.
Cet appareil répond aux exigences de la Directive Communautaire 93/42/EEC.
Dieses Gerät entspricht den Bestimmungen der EU Richtlinie 93/42/EEC.
Este aparato cumpre todas as condições da directiva 93/42/EEC.
Aparelho conforme a directiva da Comunidade Europeia 93/42/EEC.
Dette utstyret tilfredstiller kravene til EC direktivene 93/42/EEC.
Η συσκευøαυτøπληροàτις προδιαγραφûς της οδηγας 93/42/EEC της Ευρωπαàκøς Ενωσης.
Bu cihaz EC 93/42/EEC direktifleri gönergesini kars¸ılamaktadır.
Dit toestel voldoet aan de EC-richtlijn 93/42/EEC
Urzàdzenie spe∏nia wymogi dyrektywy UE 93/42/ECC
© Medel S.p.A. 2006
Vietata la duplicazione. Riproduzioni, anche parziali, in qualsiasi forma, sono vietate se non preventivamente autorizzate per iscritto dalla Medel S.p.A..
Le specifiche tecniche, la descrizione, la dotazione di accessori e l’aspetto esteriore dei prodotti possono variare senza preavviso.
Fabbricante/Manufacturer (93/42/EEC):
Designed, engineered and imported by:
Design, progetto e importazione:
MEDEL S.p.A.
S.Polo di Torrile (PR) Italy
www.medel.it
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