INTRODUCTION

The multisonic infracontrol is a powerful ultrasonic inhalation unit for preventative and therapeutic deep inhalation that reflects the latest scientific findings in this area. The unit has not been designed for life saving emergency treatment.

The multisonic infracontrol can be used at home, whilest 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 "Noisless in operation "Modern design "Small, easy to handle and transport "Suitable for the inhalation of all common inhalation solutions Please read the Instructions for Use carefully to ensure that the unit is used correctly.

DESCRIPTION

Inhalation therapy with the Multisonic®-Infracontrol Progress in medicine demands improvements in medicine delivery technology and treatments. The nebuliser, the Schill Multisonic®-infracontrol, a silent operating drug delivery device, has been developed to reduce medicine consumption and wastage. The new infrared control in the device makes the operation easier for patients and offers reliable performance. The Multisonic®-infracontrol provides good lung drug deposition, economical drug usage, easy patient compliance, incorporating compact and reliable device technology.

The effectiveness of inhalation therapy depends on the active substance reaching the required destination in the lungs. An important factor is the droplet distribution and particle size generated by the nebuliser. The smaller the droplets, the more deeply the medication can penetrate into the lungs. The bigger the droplets, the more inhalation solution remains in the area of the upper breath-ways. Effective treatment of many diseases requires that the alveoli and deep lung areas should be targeted and reached in delivery of the prescribed medication. The Multisonic® infracontrol generates an extraordinarily fine aerosol. 65% of the particles are smaller than 5µm. The aerosol therefore penetrates into deep lung areas, a prerequisite for the effectiveness of many treatment therapies.

Most nebulisers operate continuously or on press button operation. The first technique leads to high medicine consumption, because aerosol is always delivered even if the patient pauses during inhalation. This is a critical point particularly with expensive inhalation medications. The second technique requires that the patient co-ordinates breathing respiration and medication delivery from the nebuliser. This leads to difficulties and often poor compliance especially with paediatric and elderly patients.

The infrared control of the Multisonic®-infracontrol solves both problems in a simple way and is therefore a real improvement in inhalation therapy. The aerosol is generated only if the patient breathes with the appliance. The patient sucks exactly the required aerosol volume out of the nebuliser through his inspiratory flow. The infrared beam crosses the nebuliser chamber and a sensor recognises the aerosol production. This activates the piezoelectric crystal which generates the ultrasound-waves. The aerosol is generated and made available for inhalation. If the patient stops the inhalation the chamber fills itself with dense aerosol medication. This is recognized by the infrared control and the aerosol production is stopped. It then starts anew if the patient inhales again or if the fog-density decreases through condensation in the nebuliser chamber.

The Multisonic®-infracontrol requires no co-ordination of the patient. The patient can simply inhale or exhale with their own breath rhythm with mouthpiece or mask and no press button activation is necessary.

Two control lights in the device allow the checkup of the correct appliance function. The green light signals that the power supply is in order. The second light can show either yellow or red. A yellow light means that the appliance works and is generating aerosol. A red light shows that the inhalation solution is used up leaving the residual volume, or that the device function is interrupted. A visual control of the device function is possible with these controls leading to improved patient compliance during therapy treatment.

SAFETY FEATURES

When the unit reaches the residual volume or responds to the temperature protection feature the device switches itself off. When this happens unplug the device and allow the unit to cool for 5 minutes before plugging in and switching on again.

The device must be cleaned daily and consumables and filters replaced at the intervals recommended in the Instructions for Use Guide, (page 20 US version, page 24 EC version).

The patients Instructions for Use guide provides instructions and information for the patient, nursing staff and carers regarding how to use the device, get the best efficiency from the device, and how to recognise potential error conditions and trouble shooting.

In the event that an error condition or other problem presents the patient in the first instance should refer to the Trouble Shooting section (page 19 US version, page 22 EC version) of the Instructions for Use Guide. If the problem cannot be resolved the patient should contact the hospital or clinic responsible for the patient's welfare.

Optional Use of Filter

The device can be optionally fitted with an exhalation filter which prevents active ingredients present in the exhaled air from entering the surrounding environment. This minimises skin and eye irritation to the patient and potential side effects (eg headache) to the patient's carer or nurse who may be exposed to exhaled active ingredients during treatment. An optional inhalation filter can also be placed on the dome of the device.

PROTOCOL FOR USE

The protocol proceedure requires the patient or carer to understand and prepare the dose of the medication to be inhaled under the guidance of the clinician responsible for the patient's welfare.

CONTINUING IN HOME USE

Patients should be instructed on how to use the infracontrol device in the home and inhale the recommended dose of medication at the intervals recommended by the prescribing physician, who is also responsible for suggesting regular interval patient consultations during treatment.

INDICATIONS FOR USE

The multisonic infracontrol nebuliser is intended for home use, hospital use, clinic use, and when travelling by patients with respiratory disorders including:

"Bronchial asthma "Chronic obstructive bronchitis "Bronchiectasis "Mucoviscidosi "Pulmonary hypertension "Acute recurring infections "Chronic diseases of the airways with pulmonary emphysema "Cystic fibrosis NOTE

Patients under 10 years of age should be evaluated by their physician for their capacity to perform the necessary tasks associated with the use of the infracontrol nebuliser.

RECOMMENDATION

Only medicines that have been prescribed or recommended by a physician should be used with the infracontrol nebuliser. If a patient accidentally inhales medication not suitable for inhalation or for the patient's therapy then the patient's physician should be notified straight away.