schill EX2101 Multisonic Ultrasonic Nebulisers Instruction Manual

multisonic® infra Control
Inhaling with ultrasonic
GONDA Ph.D.
Instructions for Use
Susan Myong CSR 13365 IPR2021-00406
United Therapeutics EX2101

Overview of inhalation unit

Plug-in mains supply unit MN 81200 Rechargeable battery pack
(depending on design) Carrying case
(depending on design)

Dear Patient

The multisonic® infraControl is a powerful ultrasound inhalation unit for preventative and therapeutic deep inhalation that reflects the latest scientific findings in this area.
However, the unit has not been designed for lifesaving emergency treatment.
The multisonic® infraControl can be used at home, whilst travelling and in clinics thanks to its universal voltage supply options (mains or rechargeable battery pack).
The multisonic® infraControl effectively combines aerosol therapy with the need for safe inhalation that is environmentally friendly. Its innovative design prevents the release of medicines into the environment.
The comfort of patients was one of the main considerations in the design of the multisonic® infraControl.

• Universal usage
• Optimal penetration of tissues
• High nebuliser performance and short inhalation times
• Warming of aerosol
• Low wastage of medicines and ease of setting doses
• Simple and safe to use
• Easy to clean
• Noiseless in operation
• Modern design
• Small, easy to handle and transport
• Suitable for the nebulisation of all common inhalation solutions (see page 23 for list)

Please read the Instructions for Use carefully to ensure that the unit is used correctly. We would be happy to answer any questions you may have and would welcome your comments. (Service tel. No. +49 367 35/4 63-0)
The basic package comprises the following components:

• 1 hand unit
• 1 nebuliser head
• 1 mouthpiece
• 1 sealing ring
• 1 baffle plate
• 1 inhalation valve
• 1 exhalation valve
• 1 metering aid
• 1 plug-in power supply unit
• 1 carrying case
• 1 set of Instructions for Use

Points to note

• The multisonic® infraControl can be used for the nebulisation of all inhalation solutions that are water-based, including suspensions and natural therapy agents that are suitable for inhalation
• Use only medicines that have been prescribed or recommended by your physician.
• If you have inhaled the wrong medicine by mistake then inform your physician without delay.
• Fill the medicine chamber with the prescribed volume of medicine before each inhalation.
• Never inhale medicines that are left over from a previous inhalation unless your physician expressly says that you may do so.
• Breathe in quietly and uniformly. The first 3 or 4 times you inhale do not do so deeply to allow yourself time to get used to the aerosol mist.
• After breathing in hold your breath for a short time (around 2 seconds) to allow the medicine to be deposited properly in the airways.
• If you interrupt the inhalation process please switch off the unit by pressing the ON-/OFF Switch.
• Clean the multisonic® infraControl carefully after each inhalation.
• Carry out the inhalation therapy as directed by your physician.
• Never remove the nebulizer head or baffle plate if the unit is switched on.
• If the user does not use the inhalation unit in accordance with the Instructions for Use then he or she assumes liability for its safe operation.
• Check all the accessories regularly for any changes in appearance and replace the valves, nebuliserhead, mouthpiece, baffle plate and sealing ring at the intervals stated in the Instructions for Use.
• If the unit has turned itself off by reaching the residual volume or responds to temperature protection, to start at once the plug has to be removed from the socket and has to be put in at once.

Principle of function

An example of periodic inhalation

(mg) Average pulmonary deposition (NaCl 0.9%)

Using the multisonic® infraControl for the first time

Pull the stopper out of the mains socket of the unit and plug in the 12V DC plug of the plug-in power supply unit or rechargeable battery into the socket.
Plug the plug-in mains supply unit into the mains socket outlet (230V AC).
Remove the nebuliser head from the hand unit and place the hand unit on a flat surface such as a table. Ensure that all parts of the unit are fully dry before commencing the inhalation process.
Please note
The multisonic® infraControl must not be used in rooms such as bathrooms that have a high humidity level because of the danger of electric shock.

Inhalation

Fill the medicine – dose and quantity as directed by your physician – directly into the medicine chamber (max. 5 ml). Hold the hand unit at a slight angle so that no bubbles form on the ceramic during filling that might prevent or reduce the nebulisation process. (Fig. 1) Ensure that the sealing ring sits correctly and that the baffle plate is inserted correctly in the groove as shown.
Place the nebuliser head on the hand unit and turn it in the direction of the arrow until it is tight (Fig. 3).

• Always hold the hand unit vertically.
• Ensure that the medicine chamber always has medicine solution in it.
• Some drops of the medicine will cling to the walls of the nebuliser head and the chamber after use. This is a residual quantity of < 1 ml.

Fit the mouthpiece, the inhalation valve (dark blue) and the exhalation valve (light blue) onto the nebuliser head as shown. Make sure that the inhalation valve is fitted with the valve disc facing downwards and the exhalation valve with the valve disk facing upwards.
Lift up the hand unit and press the button “ON/OFF“. Two yellow function lamps light up to show that the unit is operational (Fig. 5).
A few seconds after the unit has been switched on the aerosol mist forms below the baffle plate. The mist remains within the unit until you inhale. Bring the hand unit up to your mouth. Lay the front of your tongue on the mouthpiece and put your lips around it.
Upon inhalation the corresponding quantity of aerosol will directly penetrate the airways.
Inhale the aerosol as instructed by your physician.

• Always breathe in and out through the inhalation unit.
• If you interrupt the inhalation process please switch off the unit by pressing the ON-/OFF Switch.
• If the unit has turned itself off by reaching the residual volume or responds to temperature protection, to start at once the plug has to be removed from the socket and has to be put in at once.
  

Optional use of the filter

A filter can optionally be fitted as an exhalation filter to the dome of the mouthpiece. In this case the valve is inserted from above in the opening of the filter. This filter should be used as an exhalation filter if residual quantities of active ingredient present in the exhaled air are to be prevented from entering the surrounding atmosphere (e.g., when inhaling antibiotics).
The filter, with the valve inside it, can also be placed on the dome of the nebuliser head and used as an inhalation filter.
Examples of various uses of the multisonic® infraControl Inhalation via the mouthpiece Inhalation via a mask Inhalation whilst lying down
The multisonic® infraControl indicates that inhalation is complete through the flashing of the red LED “End/Off“ and then turns itself off automatically after a few seconds if this is not triggered by pressing the ON/OFF button.
The unit can be re-filled with medicine after it has been cleaned and the inhalation process repeated. The unit has an additional safety function that is triggered if the unit reaches a preset temperature. This ensures that the unit functions reliably within a temperature range that is optimal for it and the medicine.
Continue to inhale until no more aerosol is generated and the quantity prescribed by your physician has been used up. If the 2 red function displays flash “End/ Off“ then inhalation is complete and
the unit will turn itself off. After inhalation remove the nebuliser head, the baffle plate and sealing ring from the hand unit and the mouthpiece and the valves from the nebuliser head.
Shake out the remaining quantity of medicine that cannot be nebulized and clean the hand unit and accessories as described in the cleaning and disinfection section.
Caution:
Children and persons who need
care should only use the inhalation unit under the supervision of other adults or care personnel.

Cleaning and disinfection

Please note the following The inhalation unit and accessories must be cleaned before being used for the first time, after each inhalation procedure and after storage for longer periods. The unit should be disinfected at regular intervals to destroy any micro-organisms that may be present. It is recommended that the unit be used only by a single patient, especially if the patient has chronic disease. If the hygiene recommendations of the manufacturer are not followed then life-threatening diseases may result. Micro-organisms need moisture to grow. It is therefore important that the unit and its individual parts be carefully dried after cleaning. The unit should be allowed to dry in the air or be dried using a lint-free cloth. The unit and its individual parts should be laid out on the cloth and not covered. Drying may be accelerated through the use of warm air from a hairdryer (at the lowest power setting). The unit must be separated from the mains supply before each cleaning or disinfection procedure. Check that the button “ON/OFF” has been pressed and that the yellow LED is not lit.
Pull the plug-in power supply unit out of the mains socket (230V AC). Remove the nebuliser head, valves, mouthpiece, baffle plate and sealing ring. To clean the hand unit pull the 12V DC plug out of the socket of the hand unit. It is extremely important that you insert the plug stopper into the socket on the unit so that no water can enter it (Fig. 2). Never immerse the plug-in power supply unit or the rechargeable battery pack in water as it could irreversibly damage them.

It is recommended that gloves be worn when cleaning the unit. Suitable cleaning agents include Palmolive and Fairy Ultra and Gig sept, Kohrs Olin or Sekusept may be used for disinfection. The hand unit and the accessories should be washed under warm running water. The hand unit, nebuliser head, mouthpiece, baffle plate, valves, sealing ring and filter holder should be disinfected in a plastic container that is suitable for use with disinfectants. They may be cleaned in a dishwasher or disinfected in a vaporizer. The nebuliser head, mouthpiece, baffle plate, valves, sealing ring and filter holder may be boiled or autoclaved at up to 134°C. The individual parts and the unit itself should be carefully dried after cleaning and disinfection. See the Hygiene Table on page 19.
Please note: Alternating between disinfection and autoclaving is not suitable as this would shorten the working life of the unit.
It is recommended that users in Germany use one of the disinfectants listed in the current DGHM list. Preparations based on compounds that release halogens, strong organic acids and oxygen-releasing compounds are not suitable as they may damage the material of the inhalation unit.
German Society for Hygiene and Microbiology.
Caution

• Do not use solvents such as acetone or benzene
• Do not allow water or disinfectant solution to enter the electrical connections (power socket) of the hand unit.

Disinfection in a vaporizer

| |
---|---|---

Before using the vaporizer for the first time it is very important that you read the Instructions for Use.
Remove the cover and the central section of the vaporizer. Fill the base section with water.
Place the hand unit “infraControl” with the opening facing downwards and the nebuliser head, mouthpiece, baffle plate, sealing ring, valves and filter holder on the grate of  the central section.
Now place the central section of the vaporizer on the base section.
Caution
Make sure that the socket of the 12 V inlet of the multisonic® infraControl is sealed with the stopper.

Further hygiene measures

Cover the central section and turn the vaporizer on. The water will have evaporated after approximately 20 minutes and the disinfection process will be concluded.

In the home:
After sealing the socket with the stopper the hand unit and individual parts can be cleaned in a dishwasher (open chamber side facing downwards).

In clinics:
After sealing the socket with the stopper the hand unit can be disinfected / sterilized through immersion disinfection, placing it in a chemicalthermal disinfector (60°C for 10  minutes) or in a gas sterilizer.
The nebuliser head, valves, mouthpiece, baffle plate, sealing ring and filter holder can be disinfected, gas-sterilized or autoclaved at up to 134°C as described above.
After cleaning and disinfection of the unit in a vaporizer / dishwasher or after chemical-thermal disinfection the unit must be allowed to cool for approximately 30 minutes before removing the parts and starting the next inhalation procedure.

Hygiene Table

Use of the MN 81300 rechargeable battery pack
The following instructions must be followed for the use of the rechargeable battery pack to ensure that inhalation can be carried out whilst travelling:
The rechargeable battery pack is a sealed maintenance-free unit. Do not attempt to open it or replace cells.
Never throw the battery pack into a fire.
Please do not throw the battery pack away once its service life is over – take it to a battery collection point instead.
To avoid shortening the life of the pack avoid exposing it to very intense sunlight, moisture, chemicals or extreme temperature shock.

Charging of the rechargeable battery pack: The power supply (12 V) is connected to the socket X1. The green LED 1 will light up upon connection to the power supply. The start of the charging process is indicated by repeated flashing of the yellow LED 2. The led 2 will light up continuously after approx. 3 seconds and will remain lit  throughout the duration of charging. If the battery pack has only a very low charge then the charging cycle will commence with a pulse charge in which the LED 2 will flash. Once the voltage level of the battery pack has reached the lower limit value the normal charging cycle will commence. The LEDs 3 to 7 indicate the available capacity (20% – 100%) of the battery pack. The charging process is discontinued once a value of 100% is attained and LED 2 will go out. The battery pack can only be re-charged if the charge value is < 100%. If, in the course of discharge, the LED 3 flashes as a warning then the battery pack should be recharged. If the available battery capacity falls to 0% then the unit is automatically disconnected from the battery pack.
The battery pack must then be recharged up to a capacity of > 20% (LED 3 lit up) before it can be connected to the nebuliser unit. The capacity display (LED 3 to LED 7) will always be active when the supply voltage is connected to the socket X1, or if the nebuliser unit is connected to it. The display may be activated by pressing the button T1.

• Never use a new battery pack until it has been fully charged. A new battery pack must be charged for a minimum of 4 –5 hours.
• The hand unit cannot be operated by the battery pack whilst it is being recharged.

The battery pack has been specially developed for use with the multisonic inhalation unit and is designed for an inhalation period of at least 60 minutes.
The initial charge is very important for the performance of the battery pack. The optimal operating time is reached after 2 – 3 complete charges. If used and charged correctly, the battery pack can be charged at least 500 times.
As with all Ni-MH batteries, the battery pack will only deliver its full power if it is fully charged.
If the battery pack is mistreated then its capacity will be reduced. It should not be stored at a temperature > 40 ºC. When not in use the battery pack should be stored in a  cool dry place.

Trouble shooting

If the unit malfunctions then please check the following:

• Is the unit connected to a power supply (plug-in mains supply unit or rechargeable battery pack)?
  Check that the plug is correctly inserted.

• Has the ON/OFF button been pressed?
  Press the ON/OFF button.

• Is the rechargeable battery pack charged?
  If not, recharge the battery pack as described on pages 20/21.

• Does the medicine chamber contain the correct volume of medicine?
  If not, fill the chamber with inhalation solution as described in the Instructions for Use to ensure that the nebuliser performance is optimal.

• Has the medicine chamber been treated with grease or a detergent in error?
  If so, rinse it out thoroughly with water that is warm/hot (approx. 40°C).

• Has an air bubble developed in the ultrasonic generator?
  If so, remove it carefully using a blunt instrument.

• Has the overheating protection been triggered?
  Check the quantity of medicine.
  Allow the unit to cool for approx. 5 minutes.

• Has the unit turned itself off by reaching the residual volume or responds to temperature protection, to start at once the plug has to be removed from the socket and has to be put in at once.

Recommendation

Only use medicines that your physician has prescribed or recommended.
If you accidentally inhale medicines that are not suitable for inhalation or your therapy then inform your physician straight away. You can enter the name(s) of your medicines for inhalation in the following table.
The inhalation unit has been tested with various medicines, including Atrovent®, Berotec®, Berudual®, BromhexinInhalat®, Cromoglicin-ratiopharm®, DNCG Stada®, Emser Sole®, Eucasil®, Mibrox®, Mucosolvan®, Sultanol®, Surfactant, amiloride, Pulmicort®, Colistin®, Ilo-medin®, Tobramycin®, Pulmozym®.
• The unit is not designed for emergency life-saving measures.
Respiratory disorders that can be treated with the multisonic® infraControl include the following:

• bronchial asthma
• chronic obstructive bronchitis
• bronchiectasis
• mucoviscidosis
• pulmonary hypertension
• acute recurring infections
• chronic diseases of the airways with pulmonary emphysema

Name of medicine ———–
Dosage ———–
Dilution ———–

Spare parts (consumables)

The mouthpiece, nebuliser head, inhalation valve, exhalation valve, sealing ring, baffle plate and filter holder will need to be changed according to the number of inhalations per day and the degree of wear that results from cleaning and disinfection. They must be changed at the latest after they have become unsightly or exhibit damage.
If used for the inhalation of active ingredients for which no aerosol is allowed to enter the atmosphere it is recommended that the above parts be replaced as follows:
Daily
Filter insert for the exhalation filter
Weekly
Filter insert for the inhalation filter the inhalation valve, exhalation valve and sealing ring
Every 3 months
Filter holder
Nebuliser head
Baffle plate
Mouthpiece
Please contact your specialist dealer or pharmacist if you wish to re- order consumables.

Optional Accessories

Guarantee conditions

The manufacturer, or its authorized service agents, will repair any manufacturing faults or material faults that arise during the guarantee period without charge. No claims for a cancellation of sale, reduction of purchase price or withdrawal from contract will be entertained. Any damage that results from the incorrect treatment of the unit or a failure to adhere to the Instructions for Use are excluded under this guarantee. The guarantee is invalidated if the unit has been worked on by unauthorized personnel. This guarantee excludes compensation for direct or indirect damage. If you wish to claim under this guarantee then please bring the complete unit to your specialist dealer or return it to us, adequately packed and with sufficient postage and proof of purchase. The unit is guaranteed for a period of 24 months from the date of purchase.

Important service information
The multisonic® infraControl inhalation unit is an electrically-operated unit. It must not be used without supervision, in potentially explosive atmospheres or in rooms with a high humidity.
Those using this unit must have an exact knowledge of these Instructions for Use and must adhere to the requirements presented in them. The unit must only be repaired by the manufacturer or a service agent that is authorized to do so by the manufacturer.
The unit should be transported using the shoulder bag MN 81500.
If repairs are carried out by agents authorized by the manufacturer then the customer should request a receipt giving the date, type and scope of the repair and name and address of the agent with a signature of its representative. Only original accessories may be used with the unit.
Otto Schill Medizintechnik will not assume any liability if these conditions are not adhered to.

Explanation of symbols

Technical Data – multisonic® infraControl

Type MN 81100
Noise level: <15 dB (A) (noiseless)
Nominal voltage: DC 12 V (plug-in power supply unit MN 81200)
Nominal frequency: plug-in power supply unit 50 Hz
Power consumption: 12 VA
Weight: 0.6 kg – hand unit and plug-in power supply unit
Frequency: 2.4 MHz
Nebuliser performance: approx. 0.6 ml/ min
Droplet size: MMAD dm50 approx.3.5 μm
Plug-in power supply unit MN 81200
Input voltage: AC 100 – 240 V
Output voltage: DC 12 V
Output current: 1.25 A
Nominal frequency: 50 – 60 Hz
Power consumption: 20 VA
Continuous operation: IP41
Rechargeable battery pack MN 81300
Input voltage: DC 12 V
Output voltage: DC 12 V
Ah capacity 1.5
Weight: 0.5 kg
Continuous operation: IP43
Classification
Continuous operation
Class of protection II upon operation with plug-in power supply unit MN 81200
Disinfection/sterilization as described on pages 15/ 16 MMD class IIa…. not to be used in explosive atmospheres
Type B IP 54

Otto Schill GmbH & Co. KG
Medizintechnik
Auwiesen 12
D-07330 Probstzella
Fon+49 (0) 3 67 35 /4 63 -0
Fax +49(0)36735/463-44
info@multisonic.de
www.multisonic.de
Kommunikationsbüro Ulm 0403 · Technische Änderungen vorbehalten

Read User Manual Online (PDF format)

Read User Manual Online (PDF format)  >>

Download This Manual (PDF format)

Download this manual  >>