SC 145 - Inhaler Scala - Free user manual and instructions

USER MANUAL SC 145 Scala

B2.2 B2.2.1 B2.2.2 B2.2.3

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• Keep this manual saf

Treatment of respiratory diseases. Medications must be prescribed by a doctor who has assessed the patient's general condition. CONTRAINDICATIONS

• The medical device should NOT be used for patients who are unable to breathe on their own or who are unconscious.

• Do not use the device in anaesthetic or assisted ventilation circuits. INTENDED USERS The devices are intended for use by legally authorised medical personnel/health workers (doctors, nurses, therapists, etc.). The device can be used directly by the patient.

TARGET GROUP OF PATIENTS

Adults, children of all ages, infants. Before using the device, the user manual must be read carefully and an adult responsible for safety must be present if the device is used by infants, children of any age or persons with limited abilities (e.g. physical, mental or sensory). It is up to the medical personnel to assess the patient's condition and capabilities in order to determine, when prescribing therapy, whether the patient is able to operate the aerosol safely on their own or whether the therapy should be administered by a responsible person. Please refer to medical personnel for the evaluation of the use of the device on particular types of patients such as pregnant women, lactating women, infants, incapacitated persons or persons with limited physical capabilities. OPERATING ENVIRONMENT This device can be used in healthcare facilities, such as hospitals, outpatient clinics, etc., or even at home.

WARNINGS CONCERNING POSSIBLE MALFUNCTIONS

• Should your appliance fail to perform, please contact the authorised service centre for clarication.

• The manufacturer should be contacted to report problems and/or unexpected events relating to operation and if necessary for clarication of use and/or maintenance/hygienic preparation.

• Please also refer to the case history of faults and their resolution. WARNINGS

• Use the device only as a therapeutic inhaler. This medical device is not intended as a life-saving device. Any other use is considered improper and can be dangerous. The manufacturer is not liable for any improper use.

• Always consult your general practitioner for identication of treatment.

• Follow the instructions of your doctor or respiratory rehabilitation therapist regarding the type of medicine, dosage and treatment indications.

• If you should experience allergic reactions or other problems while using the device, stop using it immediately and consult your doctor.

• Keep this manual safe for further reference.

• If the packaging is damaged or opened, contact the distributor or service centre.

• Do not expose the device to particularly extreme temperatures.

• Do not place the device near heat sources, in sunlight or in an excessively hot environment.

• The time required to switch from storage to operating conditions is about 2 hours.

• It is forbidden to access the compressor unit opening in any way. Repairs may only be carried out

by personnel authorised by the manufacturer. Unauthorised repairs invalidate the warranty and may pose a danger to the user.

• Suocation risk: - Some components of the appliance are small enough to be swallowed by children, so keep the appliance out of the reach of children.

• Strangulation risk : - Do not use the supplied connecting hose and cables outside of their intended use, they could cause a strangulation hazard, take special care for children and people with special diculties, often these people are not able to correctly assess the dangers.

• Fire risk: - THIS device is not suitable for use in the presence of an anaesthetic mixture that is ammable with air, or with oxygen or nitrous oxide.

• Risk of electrocution: - Before rst use, and periodically during the life of the product, check the integrity of the structure of the appliance and the power cord to ensure that there is no damage; if it is damaged, do not plug it in and immediately take the product to an authorised service centre or your dealer. - Keep the power cable away from animals (e.g. rodents), otherwise such animals could damage the insulation of the power cable. - Always keep the power cable away from hot surfaces. - Never obstruct the ventilation slots located on both sides of the compressor unit. - Do not handle the compressor unit with wet hands. Do not use the compressor unit in humid environments (e.g. while bathing or showering). Do not immerse the compressor unit in water; if this happens, pull the plug immediately. Do not pull out or touch the compressor unit while immersed in water, unplug it rst. Take it immediately to an authorised FLAEM service centre or your dealer.

• Risk of ineectiveness of therapy: - Performance may vary with particular types of drugs (e.g. those with high viscosity or in suspension). For further information, please refer to the package leaet provided by the drug manufacturer. - Use the nebuliser in the correct position, as upright as possible; do not tilt the nebuliser beyond an angle of 30 degrees, in any direction, to prevent the drug from spilling into the mouth or being overdispersed, reducing the eectiveness of the treatment. - Pay attention to the indications provided with the drug and avoid using the devices with sub- stances and dilutions other than those recommended. - Only use the device in a dust-free environment, otherwise therapy may be impaired. - Do not obstruct or insert objects into the lter and its housing in the unit. - In the case of substances that are too dense, dilution with suitable saline solution may be neces- sary, as prescribed by a doctor. - Only use original Flaem accessories or spare parts, no liability is accepted if non-original parts or accessories are used.

• Risk of infection : - We recommend personal use of the accessories to avoid any risk of infection. - Follow hygienic preparation before each use. Ensure that tubing and accessories are not stored in the vicinity of other accessories or devices for dierent therapies (e.g. infusions). - At the end of therapy, do not leave the medicine inside the nebuliser. - If the nebuliser is used for several types of medicine, the residues must be completely removed. Therefore, perform hygienic preparation after each inhalation, also to achieve the highest degree of hygiene and to optimise the service life and operation of the device.

• Risk of injury: - Do not place the device on a soft supporting surface such as a sofa, a bed or a tablecloth. - Always operate it on a hard surface clear of any objects. 44WARNINGS ON INTERFERENCE RISKS DURING USE IN DIAGNOSTIC IN- VESTIGATIONS This device is designed to meet the current requirements for electromagnetic compatibility. As far as EMC requirements are concerned, electromedical devices require special care when being installed and used, and are therefore required to be installed and/or used in accordance with the manufacturer's specications. Risk of potential electromagnetic interference with other devices. Mobile or portable RF radio and telecommunication devices (mobile phones or wireless connections) may interfere with the operation of electromedical devices. The device may be susceptible to electromagnetic interference in the presence of other devices used for specic diagnosis or treatment. For more information visit www.aemnuova.it. CASE HISTORY OF FAULTS AND THEIR RESOLUTION Before performing any operation, switch o the appliance and disconnect it from the mains. Problem Cause Remedy Thedevice is not working Power cable not correctly plugged into the appliance socket or mains power socket Plug the power cable correctly into the sockets The device does not nebulise or nebulises poorly The medicine was not inserted into the nebuliser Pour the right amount of medicine into the nebuliser The nebuliser has not been assembled correctly. Disassemble and reassemble the nebuliser correctly according to the connection diagram on the cover. The nebuliser is obstructed Hygienic preparation of the nebuliser. Deposits of medicine due to lack of hygienic preparation of the nebuliser impair its eciency and function. Strictly follow the instructions in the HYGIENIC PREPARATION chapter. The accessories are not properly connected to the appliance Check the correct connection between the air inlet of the appliance and the accessories (see connection diagram on cover). The pipe is bent or damaged or twisted Unwind the pipe and check it for crushing or punctures. Replace it if necessary. The air lter is dirty Replace the lter The device is louder than usual The lter is inserted Insert the lter properly into the housing If, after checking the conditions described above, the device still is not working properly, we recom- mend that you contact your trusted dealer or an authorised FLAEM service centre nearest to you. You can nd a list of all Service Centres at http://www.aemnuova.it/it/info/assistenza y and may t is ammable with

ould damage the e or o the mouth or being ts or ed in

LDPE Product packaging tube

Heat-shrinkable nebuliser lm and accessories

HDPE Sack packaging bag

In accordance with Directive 2012/19/EC, the symbol on the equipment indicates that the equipment to be disposed of (excluding accessories) is considered as waste and must therefore be subject to 'separate collection'. Therefore, the user must deliver this waste (or have it delivered) to the separate collection centres set up by the local authorities, or hand it over to the retailer when purchasing a new appliance of an equivalent type. Separate waste collection and subsequent treatment, recovery and disposal operations promote the production of equipment from recycled materials and limit the negative environmental and health eects caused by improper waste management. Unauthorised disposal of the product by the user entails the application of the administrative sanctions provided for in the laws transposing Directive 2012/19/EC of the member state or country where the product is disposed of. Nebuliser and accessories To be disposed of as general waste after a sanitisation cycle. DISPOSAL Compressor unit

NOTIFICATION OF SERIOUS EVENTS

Serious events occurring in connection with this product must be reported immediately to the manu- facturer and the competent authority. An event is considered serious if it causes or may cause, directly or indirectly, death or an unforeseen serious deterioration in a person's state of health. COUNTRY AUTHORITY Ireland Health Products Regulatory Authority Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, IE - Dublin 2 E-mail: [e-mail] Malta Medical Devices Unit Medicines Authority Sir Temi Żammit Buildings, Malta Life Sciences Park San Ġwann SĠN 3000 E-mail : [e-mail] 46INFORMATION ON RESTRICTIONS OR INCOMPATIBILITIES WITH CER- TAIN SUBSTANCES

• Interactions: The materials used in the device are biocompatible materials and comply with statutory regulations, however possible allergic reactions cannot be completely excluded.

• Use the medicine as soon as possible once it has been opened and avoid leaving it in the nebuliser; once therapy has ended, do not leave the medicine inside the nebuliser and proceed with hygienic preparation. Phthalate- and bisphenol-free IP21 Protection rating of the envelope: IP21. (Protected against solid bodies larger than 12 mm. Protected against access with a nger; Protected against vertically falling drops of water). Model number See instructions for use Temperature limits Moisture limits Atmospheric pressure limits Production date Batch Code Unique device identier Quality mark Medical device Distributor

SYMBOLS ON DEVICE OR PACKAGING

Medical CE marking ref. regulation 2017/745 EU and subsequent updates Serial number of the device Class II device Manufacturer Before use: Caution check instruc- tions for use Type BF applied part Function switch o Alternating current Function switch on Attention t the ore e it er to tion and equipment oper tion of the

sec oneself fr (solutions and susp must in an with suitable saline solution ma

APPLIED PARTS Type BF applied parts are: patient accessories (B3, B4, B5, B6) Weight: 1.500 Kg DURATION Model: P0504EM F400 (Compressor unit) Service life 400 hours. Model: RF8-3 (Nebuliser and accessories) The expected average life is 1 year, however it is advisable to replace the nebuliser every 6 months during intensive use (or sooner if the nebulis- er is clogged) to ensure maximum therapeutic eectiveness. ENVIRONMENTAL CONDITIONS Operating conditions: Ambient temperature Between +10°C and +40°C Relative air humidity Between 10% and 95% Atmospheric pressure Between 69 KPa and 106 KPa Storage and transport conditions: Ambient temperature Between -25°C and +70°C Relative air humidity Between 10% and 95% Atmospheric pressure Between 69 KPa and 106 KPa

TECHNICAL SPECIFICATIONS OF DEVICE

Model: P0504EM F400 combined RF8-3 Operating pressure (with neb.): 0.8 bar. Speed selector B2.2.3 in pos Max in pos Min (1) Release:

55.5% 61.1% (1) Data collected according to Flaem's internal procedure. (2) In vitro characterisation performed by TÜV Rheinland Italia S.r.l. in cooperation with the University of Parma. More details are available on request.

Model: RF8-3 Nebulizzatore RF8 Dual Speed Minimum drug capacity: Maximum drug capacity: 2 ml 8 ml 48OPERATING INSTRUCTIONS Before each use, wash your hands thoroughly and clean your appliance as described in the section "HYGIENE PREPARATION". During application, it is recommended to adequately protect oneself from drips. This appliance is suitable for the administration of medicinal substances (solutions and suspensions), for which aerosol administration is envisaged; such substances must in any case be prescribed by a doctor. In the case of substances that are too dense, dilution with suitable saline solution may be necessary, as prescribed by a doctor.

1. Insert the plug of the power cable (A6) into a mains

socket corresponding to the voltage of the appli- ance. It must be positioned in such a way that dis- connection from the power grid is not dicult.

2. Reassemble the upper part with the selector

switch as shown in the connection diagram sect. B2.2. Attention, the selector support (B2.2.2) must t perfectly into the upper part (B2.2.1), to do this you must align the arrow on the selector support with the accessory coupling notch, see picture.

3. Add the medicine prescribed by the doctor into

the lower part (B2.1). Insert the upper part (B2.2) into the lower part (B2.1), close the nebuliser by turning the upper part (B2.2) clockwise.

4. Connect the accessories as shown in the 'Connection Diagram' on the cover.

B2.2.1 B2.2.2 e the e use (or sooner if the nebulis-

EQUIPMENT AND MATERIAL INFORMATION

The equipment includes: Information on materials A - Compressor unit - Model: P0504EM F400 A1 - Switch A2 - Air intake A3 - Air lter A4 - Nebuliser holder A5 - Carrying handle A6 - Power cable B - Nebuliser and accessories - Model: RF8-3 B1 -Connecting tube (compressor/nebuliser unit) B2 - RF8 Dual Speed Nebuliser B2.1 - Lower part B2.2 - Upper part with selector B2.2.1 - Upper part B2.2.2 - Selector switch support B2.2.3 - Speed selector B3 - Mouthpiece Polypropylene B4 - Paediatric SoftTouch mask Polypropylene + Thermoplastic Elastomers B5 - Adult SoftTouch mask B6 - Adult nasal piece Polypropylene IMPORTANT NOTE: There is an identication label on the packaging, remove it and ax it in the spaces provided on page 2. When replacing the Nebuliser and accessories, perform the same procedure. C - Accessory pouch

49HOW TO USE THE “RF8 DUAL SPEED” NEBULISER WITH SPEED SELECTOR To speed up inhalation therapy, turn the speed selector (B2.2.3) clockwise. To make the inhalation therapy more eective, turn the speed selector (B2.2.3) anticlockwise, in this case you will achieve optimal drug administration while minimising the dispersion of the drug in the surroundings. SoftTouch masks SoftTouch masks have an outer edge made of soft, biocompatible ma- terial that ensures an optimal t on the face, and are also equipped with theinnovative Dispersion Limiter. These characteristic features allow for greater sedimentation of the drug in the patient, and again limit its dispersion. Upon inhalation, the tab, which acts as a Dispersion Limiter, bends inwards in the mask. Upon exhalation, the tab, which acts as a Dispersion Limiter, bends outwards from the mask. Soft biocompatible material Dispersion Limiter

5. Sit comfortably while holding the nebuliser in your hand, place the

mouthpiece to your mouth or use a nasal piece (if provided) or mask. If you use the mask accessory, place it on your face as shown in the gure (with or without the use of the elastic band).

6. Switch on the device by pressing the switch (A1) and inhale and ex-

hale deeply; after inhaling, it is recommended to hold your breath for a moment so that the inhaled aerosol droplets can settle. Then exhale slowly.

7. When the application is nished, switch o the device and disconnect

it from the mains. ATTENTION: If, after the therapy session, an obvious deposit of moisture forms inside the tube (B1), detach the tube from the nebuliser and dry it with the ventilation of the compressor itself; this action prevents possible mould growth inside the tube. To facilitate the connection of the connection tube (B1) to the compressor unit, act on the end of it by simultaneously rotating and inserting it, and for removal by rotating and extracting it. 50or (B2.2.3) tion while tible ma- e also equipped with

, and again limit its ts as

HYGIENIC PREPARATION Switch o the appliance before each hygienic preparation operation and disconnect it from the mains. Compressor unit (A) and pipe exterior (B1) Use only a cloth moistened with antibacterial detergent (non-abrasive and free of solvents of any kind). Nebuliser and accessories Open the nebuliser by turning the upper part (B2.2) anticlockwise, take apart the upper part (B2.2) as shown in the “Connection diagram” in point B2.2. Then proceed according to the instructions below. Sanitisation Before and after each use, sanitise the nebuliser and accessories by choosing one of the methods provided in the table and described below. method A: Sanitise the accessories under warm drinking water (approx. 40°C) with mild dishwashing detergent (non-abrasive). method B: Sanitise the accessories in the dishwasher with the hot cycle (70°C). method C: Sanitise the accessories by soaking in a solution of 50% water and 50% white vinegar, then rinse thoroughly with warm drinking water (approx. 40°C). After sanitising the accessories, shake them vigorously and place them on a paper towel, or alternatively dry them with a hot air jet (e.g. hair dryer). Disinfection After sanitising the nebuliser and accessories, disinfect them using one of the methods provided in the table and described below. Each method can be performed for a limited number of times (see gure in table). method A: Obtain a disinfectant of the electrolytic chloride type (active ingredient: sodium hypochlorite), specically for disinfection, available in all pharmacies. Execution: - Fill a container of a suitable size to hold all the individual components to be disinfected with a solution of drinking water and disinfectant, observing the proportions indicated on the packaging of the disinfectant. - Completely immerse each individual component in the solution, taking care to avoid the formation of air bubbles in contact with the components. Leave the components immersed for the period of time indicated on the disinfectant packaging, and associated with the concentration chosen for the preparation of the solution. - Recover the disinfected components and rinse them thoroughly with lukewarm drinking water. - Dispose of the solution according to the disinfectant manufacturer's instructions. method B: Disinfect accessories by boiling them in water for 10 minutes; use demineralised or distilled water to avoid hard water deposits. method C: Disinfect the accessories in a hot bottle steamer (not microwave). Carry out the process strictly according to the hot bottle steamer's instructions. For disinfection to be eective, choose a steriliser with an operating cycle of at least 6 minutes. After disinfecting the accessories, shake them vigorously and place them on a paper towel, or alternatively dry them with a hot air jet (e.g. hair dryer). At the end of each use, store the device complete with its accessories in a dry and dust-free place. wth inside the t on the end of it by 51Accessory patient Method Table of planned methods / patient accessories Sanitisation Disinfection method

MAX 300 TIMES ✓: planned \: not planned AIR FILTRATION The appliance is equipped with an extraction lter (A3) to be replaced with a replacement lter (D1) when it is dirty or changes colour. Do not wash or re-use the same lter. Regular replacement of the lter is necessary to help ensure proper compressor performance. The lter must be checked on a regular basis. Contact your dealer or authorised service centre for replacement lters. To replace the lter, pull it out as shown in the gure. The lter is designed so that it is always tted in its housing. Do not replace the lter during use. Only use original Flaem accessories or spare parts, no liability is accepted if non-original parts or accessories are used.