SC 145 - Inhaler Scala - Free user manual and instructions

Product type	Inhaler for aerosol therapy
Brand	Scala
Model	SC 145 (compressor P0504EM F400, nebulizer RF8-3)
Dimensions (L x W x H)	16 x 20 x 12 cm
Weight	1.5 kg
Power supply	230 V ~ 50 Hz
Power consumption	130 VA
Maximum pressure	1.8 ± 0.3 bar
Compressor air flow	Approx. 9 l/min
Noise level	54 dB(A) at 1 m
Nebulizer capacity	2 ml (min) - 8 ml (max)
Compressor lifespan	400 hours
Nebulizer lifespan	1 year (replace every 6 months in case of intensive use)
Applied part type	BF (patient accessories)
Protection rating	IP21
Intended users	Medical staff and patients (adults, children, infants)
Operating environment	Healthcare facilities or home
Main functions	Aerosol therapy, dual-speed nebulizer with flow selector
Maintenance and cleaning	Regular cleaning and disinfection of accessories, replacement of air filter
Safety	Warnings against electrocution, fire, suffocation, strangulation; keep out of reach of children
Spare parts and repairability	Use only original Flaem accessories; repairs by authorized personnel
Symbols on the device	CE marking, class II, IP21, caution, etc.

Frequently Asked Questions - SC 145 Scala

How to use the Scala SC 145 inhaler?

Assemble the nebulizer by inserting the upper part with the speed selector into the lower part containing the medication. Connect the accessories (mouthpiece or mask). Plug in the device, turn it on, and breathe deeply through the mouthpiece or mask. Turn off after use and clean.

What medications can I use with this inhaler?

Use only medications prescribed by a doctor for aerosol therapy (solutions or suspensions). If the medication is too viscous, dilute it with saline solution according to medical recommendations.

How to clean and disinfect the nebulizer?

After each use, disassemble the nebulizer and clean it with warm water and a mild detergent, in a dishwasher (70 °C), or with diluted white vinegar. For disinfection, use a sodium hypochlorite solution, boil for 10 minutes, or a steamer (6 min). Rinse and dry thoroughly.

How often should I replace the air filter?

Replace the air filter when it is dirty or has changed color. Check it regularly. Use only original Flaem replacement filters.

What to do if the device does not work?

Check the power cord connection, medication insertion, nebulizer assembly, tube condition (not kinked), and filter cleanliness. If the problem persists, contact an authorized Flaem service center.

Is this inhaler safe for children and infants?

Yes, but under the supervision of a responsible adult. Use the provided pediatric mask. Read the instructions carefully and follow the doctor's advice.

What are the contraindications for use?

Do not use the device on unconscious patients or those unable to breathe independently. Do not use in anesthesia or assisted ventilation circuits.

How does the nebulizer speed selector work?

Turn the selector clockwise to speed up the treatment (higher flow rate) and counterclockwise for more efficient treatment (finer particles, less dispersion).

What is the lifespan of the compressor and nebulizer?

The compressor has a lifespan of 400 hours. The nebulizer is designed to last about 1 year, but it is recommended to replace it every 6 months with intensive use.

Can I use accessories from other brands?

No, use only original Flaem accessories and spare parts to ensure safety and efficacy. Use of non-original accessories voids the warranty.

USER MANUAL SC 145 Scala

C Accessory Bag

A4 A1 A6

A = # P0504EM F400

B = # RF8-3

VORGESEHENE BENUTZER\*INNEN

B2.2.1 B2.2.2

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B2.2.1 B2.2.2

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REŽIMY POUŽITÍ NEBULIZÁTORU „RF8 DUAL SPEED“ S PŘEPÍNAČEM RYCHLOSTI

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Prístroj na aerosólovú terapiu

B2.2.1 B2.2.2

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B2.2.1 B2.2.2

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Diagram of a car wheel with a handle and gear mechanism (no text or symbols)

Aerosol therapy device

These user instructions are provided for P0504EM F400 and RF8-3 model devices. The FLAEM Aerosol Therapy device consists of a compressor unit (A), a nebuliser and some accessories (B).

INTENDED USE

Medical device for the administration of medication through inhalation, with inhalation therapy and medication prescribed by a Doctor.

INDICATIONS FOR USE

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 clarification.
• The manufacturer should be contacted to report problems and/or unexpected events relating to operation and if necessary for clarification 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 identification 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.

- Suffocation 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 difficulties, 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 flammable with air, or with oxygen or nitrous oxide.

- Risk of electrocution:

- Before first 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 first. Take it immediately to an authorised FLAEM service centre or your dealer.

- Risk of ineffectiveness 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 leaflet 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 effectiveness of the treatment.

- Pay attention to the indications provided with the drug and avoid using the devices with substances 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 filter and its housing in the unit.

- In the case of substances that are too dense, dilution with suitable saline solution may be necessary, 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 different 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.

WARNINGS ON INTERFERENCE RISKS DURING USE IN DIAGNOSTIC INVESTIGATIONS

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 specifications. 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 specific diagnosis or treatment. For more information visit www.flaemnuova.it.

CASE HISTORY OF FAULTS AND THEIR RESOLUTION

Before performing any operation, switch off the appliance and disconnect it from the mains.

Problem Cause Remedy
The device 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 efficiency 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 filter is dirty Replace the filter
The device is louder than usual	The filter is inserted Insert the filter properly into the housing

If, after checking the conditions described above, the device still is not working properly, we recommend that you contact your trusted dealer or an authorised FLAEM service centre nearest to you. You can find a list of all Service Centres at http://www.flaemnuova.it/it/info/assistenza

DISPOSAL

Compressor unit

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 effects 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.

Packaging

Product box

Heat-shrinkable nebuliser film and accessories

Product packaging tube

Sack packaging bag

NOTIFICATION OF SERIOUS EVENTS

Serious events occurring in connection with this product must be reported immediately to the manufacturer 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 AuthorityKevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, IE - Dublin 2E-mail: [e-mail]
Malta	Medical Devices Unit Medicines AuthoritySir Temi Żammit Buildings, Malta Life Sciences ParkSan Ġwann SĞN 3000E-mail : [e-mail]

SYMBOLS ON DEVICE OR PACKAGING

CE0051	Medical CE marking ref. regulation 2017/745 EU and subsequent updates		Serial number of the device
	Class II device Manufacturer		Type BF applied part
	Before use: Caution check instructions for use
	Function switch off Alternating current
	Function switch on Attention		Protection rating of the envelope: IP21. (Protected against solid bodies larger than 12 mm. Protected against access with a finger; Protected against vertically falling drops of water).
	Phthalate- and bisphenol-free
	Model number See instructions for use
	Temperature limits Moisture limits
	Atmospheric pressure limits Production
	Batch Code Unique device identifier
		Quality mark Medical device	[Distributor]

INFORMATION ON RESTRICTIONS OR INCOMPATIBILITIES WITH CERTAIN 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.

COMPRESSOR UNIT SPECIFICATIONS

Model: P0504EM F400

Power supply:	230V~ 50Hz 130VA
Max. pressure:	1.8 ± 0.3 bar
Air flow to compressor:	9 l/min approx
Noise level (at 1 m):	54 dB (A) approx
Operation:	Continued
Dimension: 16(L) × 20(W) × 12(H) cm

NEBULIZER TECHNICAL SPECIFICATIONS

Model: RF8-3

Nebulizzatore RF8 Dual Speed
Minimum drug capacity:	2 ml
Maximum drug capacity:	8 ml

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:	0.40 ml/min approx. 0.19 ml/min approx.
(2) MMAD:	4.48 μm 4.01 μm
(2) Respirable fraction < 5 μm (FPF):	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.

APPLIED PARTS

Type BF applied parts are: patient accessories (B3, B4, B5, B6)

Weight: 1.500 Kg

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

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 nebuliser is clogged) to ensure maximum therapeutic effectiveness.

EQUIPMENT AND MATERIAL INFORMATION
The equipment includes: Information on materials
A-	Compressor unit - Model: P0504EM F400A1 - SwitchA2 - Air intakeA3 - Air filterA4 - Nebuliser holderA5 - Carrying handleA6 - Power cable
B-	Nebuliser and accessories - Model: RF8-3B1 -Connecting tube (compressor/nebuliser unit)B2 - RF8 Dual Speed NebuliserB2.1 - Lower partB2.2 - Upper part with selectorB2.2.1 - Upper partB2.2.2 - Selector switch supportB2.2.3 - 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 identification label on the packaging, remove it and affix it in the spaces provided on page 2. When replacing the Nebuliser and accessories, perform the same procedure.
C-	Accessory pouch

OPERATING 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 appliance. It must be positioned in such a way that disconnection from the power grid is not difficult.

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 fit 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.

1. 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.

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

B2.2.1 B2.2.2

1. 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 figure (with or without the use of the elastic band).
2. Switch on the device by pressing the switch (A1) and inhale and exhale deeply; after inhaling, it is recommended to hold your breath for a moment so that the inhaled aerosol droplets can settle. Then exhale slowly.
3. When the application is finished, switch off 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

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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.

HOW TO USE THE "RF8 DUAL SPEED" NEBULISER WITH SPEED SELECTOR

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To speed up inhalation therapy, turn the speed selector (B2.2.3) clockwise.

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To make the inhalation therapy more effective, 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

Soft biocompatible material

Dispersion Limiter

SoftTouch masks have an outer edge made of soft, biocompatible material that ensures an optimal fit on the face, and are also equipped with the innovative 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.

HYGIENIC PREPARATION

Switch off 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 figure in table).

method A: Obtain a disinfectant of the electrolytic chloride type (active ingredient: sodium hypochlorite), specifically 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 effective, 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.

Table of planned methods / patient accessories
Accessory patient\Method		Sanitisation Disinfection			____
		method A	method B	method C	method A	method B	method C
	B2.1	√ √ √			√MAX 300 TIMES	√MAX 300 TIMES	√MAX 300 TIMES
	B2.2.1	√ √ √			√MAX 300 TIMES	√MAX 300 TIMES	√MAX 300 TIMES
	B2.2.2	√ √ √			√MAX 300 TIMES	√MAX 300 TIMES	√MAX 300 TIMES
	B2.2.3	√ √ √			√MAX 300 TIMES	√MAX 300 TIMES	√MAX 300 TIMES
	B3	√ √ √			√MAX 300 TIMES	√MAX 300 TIMES	√MAX 300 TIMES
	B4	√ √ √			√MAX 300 TIMES	√MAX 300 TIMES	√MAX 300 TIMES
	B5	√ √ √			√MAX 300 TIMES	√MAX 300 TIMES	√MAX 300 TIMES
	B6	√ √ √			√MAX 300 TIMES	√MAX 300 TIMES	√MAX 300 TIMES
√:planned \: not planned

AIR FILTRATION

The appliance is equipped with an extraction filter (A3) to be replaced with a replacement filter (D1) when it is dirty or changes colour. Do not wash or re-use the same filter. Regular replacement of the filter is necessary to help ensure proper compressor performance. The filter must be checked on a regular basis. Contact your dealer or authorised service centre for replacement filters.

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To replace the filter, pull it out as shown in the figure.

The filter is designed so that it is always fitted in its housing. Do not replace the filter during use. Only use original Flaem accessories or spare parts, no liability is accepted if non-original parts or accessories are used.

B2.2.1 B2.2.2

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B2.2.1 B2.2.2

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DE> Die Garantie wird vom örtlichen Händler gewährt, der das Gerät gemäß den geltenden Gesetzen verkauft hat.
CZ> Záruka je poskytována místním prodejcem, který prodal zařízení v souladu s platnými zákony.
SK> Záruka je poskytovaná miestnym predajcom, ktorý predal zariadenie v súlade s platnými zákonmi.
HU> A garancia a helyi kereskedő által van biztosítva, aki a készüléket az érvényes törvényeknek megfelelően értékesítette.
EN> The warranty is provided by the local retailer who sold the device in accordance with applicable laws.
FR> La garantie est fournie par le détaillant local qui a vendu l'appareil conformément aux lois applicables.
NL> De garantie wordt verstrekt door de lokale verkoper die het apparaat heeft verkocht in overeenstemming met de geldende wetten.

SCALA Electronic GmbH

Ruhlsdorfer Str. 95

14532 Stahnsdorf, Germany

www.scala-electronic.de

FLAEM NUOVA S.p.A.

Via Colli Storici, 221/223/225

25015 S. MARTINO DELLA BATTAGLIA

(Brescia) – ITALY

Tel. [phone]

www.flaem.it

© 2023 FLAEM NUOVA®

All right reserved

Cod. 20331 rev. date 10/2023