INN-011 - Inhaler Innoliving - Free user manual and instructions

Product Type	Piston Compressor Nebulizer (Aerosol Therapy)
Model	INN-011
Brand	Innoliving
Dimensions	185 × 162 × 170 mm
Weight	1.6 kg
Power Supply	230 V~50 Hz, 0.6 A
Max Pressure	3 bar
Air Flow	6–9 L/min
Medicine Cup Capacity	6 mL max
MMAD (Particle Size)	2.8 ± 0.1 μm
Aerosol Output	1.98 ± 0.01 mL
Aerosol Output Rate	0.07 ± 0.01 mL/min
Drug Residue	0.5–1.3 mL
Noise Level	≤ 64 dBA
Operating Time Limit	20 minutes ON, then 40 minutes OFF
Operating Temperature	10°C to 40°C (50°F–104°F)
Operating Humidity	30%–75% RH
Protection Grade	IP21
Safety Class	Class II, Type BF
Risk Class	IIa (Medical Device)
Filter Life	Up to 500 hours or 6 months
Accessories Included	Mouthpiece, Adult Mask, Air Tube, Nebulizer Cup
Cleaning	Disassemble and wash with warm soapy water; DO NOT wash tubing; disinfect with vinegar solution
Intended Use	Prescription aerosol therapy for respiratory conditions

Frequently Asked Questions - INN-011 Innoliving

How do I connect the accessories to the nebulizer?

Refer to Figure 1 in the manual. Connect one end of the air tube to the nebulizer cup and the other end to the air outlet on the compressor. Then attach the mouthpiece or mask to the top of the nebulizer cup.

What is the maximum amount of medicine I can put in the cup?

Do not exceed 6 mL of medication per treatment. If you accidentally pour more, empty the cup, clean it, and refill with the correct amount.

How should I clean the nebulizer after each use?

Disconnect the tubing. Wash all parts (except tubing) with warm water and liquid dish soap. Rinse thoroughly, shake off water, and air dry on a clean cloth. Do not submerge the compressor or wash the tubing.

How often should I replace the air filter?

Replace the air filter every 500 hours of use or every 6 months, whichever comes first. Also replace it immediately if it becomes wet or clogged.

Can I use the nebulizer while sleeping or drowsy?

No. Never use the device while sleeping or if you feel drowsy. Always remain awake and alert during treatment.

What should I do if the nebulizer tubing has moisture inside?

Run the compressor with only the tubing attached for 2–3 minutes to dry it. Alternatively, remove the tubing and hang it with ends down to allow moisture to drain and evaporate.

Is the Innoliving INN-011 suitable for children?

No. The manual states that the device cannot be used by or on children. It is intended for adult use only under medical prescription.

What does MMAD mean and what is its value?

MMAD stands for Mass Median Aerodynamic Diameter, indicating particle size. For this device, it is 2.8 ± 0.1 μm, suitable for deep lung deposition.

Can I use the nebulizer with oxygen?

No. Do not operate the device where oxygen is being administered in a closed environment such as an oxygen tent.

What should I do if the nebulizer diffuser is clogged?

If the diffuser inside the nebulizing bulb is obstructed, the aerosol flow will decrease or stop. Do not use it; contact the after-sales service for a replacement bulb.

USER MANUAL INN-011 Innoliving

INN-011

MANUALE D'USO

USER MANUAL

MANUALE D'ISTRUZIONE

Close-up of a medical or laboratory device with a glass cap and tubing (no visible text or symbols)

BOCCAGLIO

Medical illustration of a medical device with tubing and a transparent casing (no text or symbols visible)

MASCHERA ADULTI

COME COLLEGARE GLI ACCESSORI (FIG.1):

Thanks for having purchased INNOLIVING nebulizer.

Before starting using the appliance, please read carefully all the instructions

below. It is advisable to save this instruction manual for a future use.

INN-011 is a portable medical device intended to aerosolize physician-prescribed medication which inhaled through a mouth piece or mask. A nebulizer may be used instead of a metered dose inhaler. The device consists of a compressor unit and nebulizing attachments. Illustrations of the compressor unit, tubing and accessories are on page 14.

WARNINGS

- This is a medical device and is to be used only upon medical prescription and to be operated in accordance with this manual. It is important that the patient reads and understands the information provided for the use of the unit. Do not use the device for other use than Nebulizer for Aerosoltherapy. Manufacturer will not be held responsible for inappropriate use of the device. The device should be used only with original accessories shown in this manual

• The device cannot be used by/on children.

- The device cannot be used by women during pregnancy or breastfeeding.

• Device not suitable for anaesthesia and lung ventilation

- Use the device and its accessories as your doctor's recommendations. Use medications prescribed by your doctor according to his indications

- The device does not come in sterile pack; always carry out cleaning operations before and after each treatment. When using the device follow ordinary

- hygiene and cleaning precautions, (wash your hands and carry out cleaning operations as described in the specific section of this manual)

• The device has small components which might be removed and

easily swallowed. Do not leave the device unattended in places easily accessible by minors and disabled people.

- Before connecting the appliance, check the voltage shown on the rating label corresponds to the local mains voltage.

- Before starting using the appliance, please check the product is not damaged. In case of doubts, Never use the appliance, if the power cord or the plug is damaged. If the product is damaged please address to the after sales service.

- Do not insert objects into any openings. Do not block air inlets.

- Never use the appliance while you are sleeping or if you feel drowsy.

- Never use an extension cord or electrical adapter.

- Keep the cord away from heated surfaces.

- Do not handle the plug with wet hands, and not use the product while bathing. Never submerge the unit into water; should this occur, unplug immediately. Do not reach for a product that has fallen into water; unplug it first. After removing the product from the water, do not use it again (contact the after sales service).

- Always store the device in a dry and clean place far from light, heat and weather Unplug always the product from the mains before cleaning, replacing accessories and whenever a disturbance occurs.

• Service should be performed only by authorized repair service. Unauthorized repair voids the warranty. Contact the after sales service at the number shown on the warranty card and gift box.

- Dispose of device as provided by standards in force

• This appliance is not for unattended use.

- Do not operate where oxygen is being administered in a closed environment such as an oxygen tent.

- Do not use the nebulizer while operating a vehicle

• Never use when sleeping or drowsy.
• Any patient who is unable to use a mouthpiece properly under supervision should use a mask.
• Use only with nebulizers, tubing and accessories authorized provided for this device. Other nebulizers tubing and accessories
• may result in improper treatment.
• Do not open or disassemble the compressor for any reason Other compressor
• and tubing may produce incorrect flow, resulting in improper dosage.
  EMI/RFI recommendations:

a. Do not turn or use hand-held personal electronic equipment communication devices such as a cellular phone, walkie talkies and CB radios while the compressor is turned ON.
b. Be aware of any nearby transmitters (radio, television, microwave, etc..) and avoid operating the compressor close to any of these transmitters.
c. Turn off the power if the compressor is not going to be used for any length of time
d. Be aware that adding accessories or components or modifying the compressor may make it more susceptible to EMI/RFI

MICROBIC CONTAMINATION

In the presence of pathologies with the risk of infection and microbial contamination, a personal use of the accessories and the nebulizing bulb is suggested (always consult your physician).

1. Tubing and accessories are for single patient use only. Do not share your tubing and accessories with other patients.

2. To reduce the risk of increased bacterial growth, infection, illness or injury from contamination, thoroughly clean and dry all parts of tubing and accessories and thoroughly dry any moisture or condensation in the tubing at the end of every treatment, following the instructions below.

3. Cleaning the Nebulizer unit after each treatment is not enough. The tubing and accessories must also be regularly cleaned and disinfected between treatments to prevent serious or fatal illness caused by contamination.

4. Never use tubing with a clogged nozzle. if the nozzle is clogged, the aerosol mist will be reduced, altered or stopped, which will diminish or eliminate the effectiveness of the treatment. if clogging occurs, replace with the same model.
5. Close supervision is necessary when this product is used by or near children and physically or mentally impaired persons.
6. This product contains small parts that may present a choking hazard to small children. The tubing also presents a strangulation hazard.
7. Before use, check tubing and accessories for proper assembly. All parts should be seated firmly in place. Use of improperly assembled tubing and accessories could diminish or prevent adequate delivery or medication and the effectiveness of the treatment.

ACCESSORIES:

Close-up of a medical device with a glass cap and tubing (no visible text or symbols)

MOUTH PIECE

Medical device with transparent casing and tubing, no visible text or symbols

ADULT MASK

HOW TO CONNECT THE ACCESSORIES (PICTURE.1):

1. air tube
2. medicine cup

3. inner insert

4. top of nebulizing bulb

5. adult mask
6. mouth piece

INSTRUCTIONS FOR USE

Wash hands with soap and warm water and dry completely with a clean towel.

Plug the power cord into the electrical outlet corresponding to the voltage of the unit. The device is not sterile. Before use carry out cleaning and disinfection operations as described in the specific section to pour the medication rotate the nebulizer top counter clockwise and remove it. For the quantity of medication prescribed by your doctor into the nebulizer tank.

IMPORTANT: Never drop more than 6ml medicine into the cup for each treatment. In case you do so, empty the nebulizer, clean it thoroughly and proceed with new filling. When medication has been poured, connect the nebulizer top onto the tank, rotate clockwise and insert the accessory prescribed by your doctor into the nebulizer top. Firmly connect one end of the air tube to the nebulizer and the other end to the air outlet on the compressor nebulizer for aerosoltherapy. Start the compressor for treatment to begin.

IMPORTANT: NEVER INHALE IN HORIZONTAL POSITION. NEVER BEND THE NEBULIZER OVER 60°.

When the application has finished, turn the unit off and carefully clean the accessories. Replacing the spare filter: lift the filter support lid by levering with a flat-ended screwdriver; detach the filter to be replaced and insert the spare filter.

Finally, insert the filter support lid into its seat, making it adhere well to the surface. In order to lengthen the life of the nebulizer, do not use it continuously for more than 20 minutes. Always wait 40 minutes before using it again.

CLEANING AND MAINTENANCE

Do not wash the unit under running water or do not submerge it in to water; wipe it only with a damp cloth using mild detergents. Do not use abrasive cleaners.

CLEANING THE NEBULIZER COMPONENTS AND ACCESSORIES:

1. Disconnect the tubing from the compressor and from the bottom of the nebulizer cup

2. If there is any moisture (condensation) in the tubing, let the compressor run with the tubing only 2-3 minutes. the warm air from the compressor will dry out the tubing. Alternatively you can dry the tubing by removing it from the compressor and hanging it up with the "ends down" to allow the moisture or condensation to drain out and evaporate. use a clean damp cloth to wipe the exterior of the tubing.

3. Disassemble tubing and accessories as illustrated

4. Wash all parts with warm water and liquid dish soap. DO NOT WASH THE TUBING.
5. Rinse thoroughly with warm water and shake out water
   6 Air dry or hand dry nebulizer parts on a clean, lint free cloth. reassemble nebulizer when parts are dry and store them.
6. you can also wash the accessories in the top shelf of a dishwasher. Masks cannot be washed safely in a dishwasher. DO

NOT WASH THE TUBING. Place the parts in a dishwasher basket and place the basket on the top rack of the dishwasher. Remove and dry parts when the cycle is complete.

CLEANING THE COMPONENTS NEBULIZER COMPONENT

1. Clean the nebulizer components ad accessories as described in cleaning section. Soak the parts in a solution of 1 part distilled white vinegar and 3 parts hot tap water for 1 hour. DO NOT SOAK THE TUBING. You can substitute commercially available respiratory equipment disinfectant for distilled white vinegar by following manufacturer's instructions for mixing.
2. Rinse all parts thoroughly with warm tap water and dry with a clean, lint-free cloth. Discard vinegar solution when disinfecting is complete.

ATTENTION: never use the nebulizing bulb when the diffuser inside is obstructed. If the diffuser is obstructed, the nebulizing flow will decrease, or even stop and the medicine effect will be reduced. In this case, contact the after sales service for the replacement of the nebulizing bulb.

CLEANING OF AIR FILTER

The air filter of the compressor unit is bright white when new. With use, the air filter will turn to grey, which means it's time to replace it. It must be replaced immediately if it gets wet or become clogged. The air filter lasts up to 500 hours of use before replacement. A general rule is to replace it whenever the nebulizer unit is replaced and after 6 months.

To replace the air filter, ensure the compressor is off, open the air filter cover, take out the air filter and replace it with a new one. Place the cap back into the socket and snap the filter cover back to place.

NOTE: do not attempt to wash and reuse the air filter. Do not use substitute filter material. Compressor damage may result.

INFORMATION TO USERS according to Legislative Decree No. 49 of March 14, 2014 "2012/19/UE Implementation of the Directive on Waste Electrical and Electronic Equipment (WEEE)"

The crossed-out dustbin symbol indicates that the product at the end of its life must be collected separately from other waste. The user should, therefore, take the equipment with the essential components at the end of its useful life to the separate collection center of electronic and electrical waste, or return it to the retailer when purchasing new equipment of equivalent type, in ratio of one to one, or one to zero for devices with larger side less than 25 CM. The separate collection for the decommissioned equipment for recycling, treatment and environmentally compatible disposal contributes to avoid possible negative effects on the environment and human health and promotes recycling of the materials. Improper disposal of the product by the user entails the application of administrative sanctions according to Legislative Decree No. 49 of 14 March 2014.

SYMBOLS:

Class II appliance

Class II appliance

Type BF applied parts

IP21 protection grade

1936

The appliance has been built in compliance with European directive 93/42/EEC concerning medical devices. Thereby it conforms to all the applicable directives.

Read instruction manual for important cautionary information such as warnings and safety norms

The medical device contains phthalates

DEHP

Innoliving Spa Via Merloni 2/B - 60131 Ancona - Italy

INN-011 Piston compressor nebulizer - Aerosol a pistone 230V\~50Hz 0,6A

TEMPO MASSIMO LAVORO: 20min TEMPO MINIMO RIPOSO 40 min

IP21

MADE IN CHINA

LOT

do not open the device, refer to the manufacturer.

and with the prescribed medication.

TECHNICAL SPECIFICATIONS:

Piston electrocompressor with thermal cut-out

Nominal voltage: see rating label

Dimensions: 185*162*170 mm

Size: 1,6 kg

Not continuous use compressor: 20 min ON/40 min OFF

Class of risk: IIa

Maximum pressure: 3 bar

Air flow: 6\~9 l/min

Capacity of Medicine cup: 6 c.c.

MMAD (μm): 2,8+/- 0,1

Drug residues: 0.5\~1.3 c.c.

Maximum sound pressure value : 64 dBA

Aerosol output (ml): 1.98±0.01

Aerosol output rate (ml/min): 0.07±0.01

Operating requirements Temperature: 10°C\~40°C (50°\~104°F)

Humidity: 30% \~ 75% RH - High hydrostatical pressure: 860-1013hPA

Storage and transportation requirements Temperature: -25°C \~ +70°C (+13°\~158°F)

Humidity: 10 \~ 90% RH - High hydrostatical pressure: 860-1060 hpa

The information provided by Innoliving Spa in accordance with EN 13544-1 are not applied to medicines provided in suspension or other viscosity. In such cases, these information must be given by the supplier of the medicine.

The product is designed to work with a rating up to an altitude of 3000 m. The electro-medical device requires special precautions regarding EMC (Electromagnetic Compatibility) and must be installed and put into service in accordance with the EMC information contained in the accompanying documents.

Portable and mobile radiocommunication equipment can affect the operation of the EUT (Equipment under test).

The use of accessories, transducers and cables other than those specified, with the exception of those sold by the manufacturer as spare parts for internal components, may cause an increase in emissions and a decrease in immunity.

The appliance or system must not be used near other appliances and, if it is necessary to use it near other appliances, the electro-medical device must be observed to check normal functioning in the configuration in which it is used.

The electro-medical device has been tested and found to comply with the emission and immunity limits of electromedical equipment according to IEC60601-1-2: 2014. These limits are designed to provide adequate protection against harmful interference in a typical medical installation. However, there is no guarantee that interference will not occur in a particular installation.

If the electro-medical device, interacting with another device, causes or receives detectable interference, the user is invited to limit interference by adopting one or more of the following measures:

1. reorient or relocate the receiving device;
2. increase the distance between the appliances;
3. connect the equipment to an outlet on a circuit different from the device (s) causing the interference;
4. contact the manufacturer or local technician for assistance

Manufacturer's guide and declaration – electromagnetic emissions
INN-011 is intended to be used in the electromagnetic environment specified below. The patient or use of INN-011 should assure it's used in this environment.
Emission test Compliance Electromagnetic environment
Emissions at RF CISPR 11 Group1 INN-011 uses radio frequency energy only for its internal functioning. As a result, its RF emissions are very low and are unlikely to cause any interference in nearby electronic devices.
Emissions at RF CISPR 11 Class B INN-011 is suitable for use in all domestic markets and connected directly to the public power voltage grid.
Harmonic emissions IEC 61000-3-2 Class A
Voltage fluctuations/flicker emissions IEC 61000-3-3	Compliant

Manufacturer's guide and declaration - electromagnetic immunities
INN-011 is intended to be used in the electromagnetic environment specified below. The patient or use of INN-011 should assure it's used in this environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment
Electrostatic discharge (ESD)IEC 61000-4-2	±8kV contact ±8kV contact Floors must be made of wood, concrete or ceramic tiles. If the floors are covered with synthetic material, the relative humidity should be at least 30%.
	±2; 4; 8; 15 kV in air ±2; 4; 8; 15 kV in air
Fast electrical transients / pulse sequence	±2kV for power lines ±2kV for power lines		The quality of the mains voltage should be that of a typical commercial or hospital environment.
OvervoltageIEC 61000-4-5	±0,5; 1kV between phases ±0,5; 1kV between phases		The quality of the mains voltage should be that of a typical commercial or hospital environment.
Voltage dips, brief interruptions and voltage variations on the power input linesIEC 61000-4-11	0% UT per 0,5 cycles 0% UT per 0,5 cycles		The quality of the mains voltage should be that of a typical commercial or hospital environment. If the user of INN-011 requires continued operation during power mains interruptions, it is recommended to use INN-011 with a UPS or batteries.
	0% UT per 1 ciclo 0% UT per 1 ciclo
	70% UT per 25 cycles 70% UT per 25 cycles
	0% UT per 250 cycles 0% UT per 250 cycles
High frequency electromagnetic field (50/60Hz)IEC 61000-4-8	30 A/m 30 A/m Power frequency magnetic fields		should have features of a typical location in a commercial or hospital environment.
NOTE U_t is the mains voltage before applying the test level.
INN-011 is intended to be used in the electromagnetic environment specified below. The patient or use of INN-011 should assure it's used in this environment. Portable and mobile RF communications equipment should not be used closer to any part of, including cables, than the recommended separation distance calculated with the equation applicable to the transmitter frequency.
Immunity test IEC 60601 test level Compliance			level	Recommended separation distance d:
Conducted RF IEC 61000-4-6	3 Veff from 150kHz to 80 MHz6 Veff in ISM amateurs bands between 150 KHz and 80 MHz		3 Veff&6Veff d=30 cm
Irradiated RF IEC 61000-4-3	10 V/m from 80 MHz to 2,7 GHz 10 V/m d=30 cm
Proximity field immunity from wireless RF communication devicesIEC 61000-4-3	TETRA 400380-390 MHz	27 V/m 27 V/m d=30 cm
	GMRS 460 FRS 460430-170 MHz	28 V/m 28 V/m
	LTE Band 13, 17704-787 MHz	9 V/m 9 V/m
	GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5800 960 MHz	28 V/m 28 V/m
	GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 51700-1990 MHz	28 V/m 28 V/m
	Bluetooth, WLAN, 802.11 b/g/n, RIFD 2450, LTE Band 702400-2570 MHz	28 V/m 28 V/m
	WLAN 802.11 a/n5100-5800 MHz	9 V/m 9 V/m

innoliving

Innoliving Spa

Via Merloni, 2/B

60131 Ancona Italy

Tel [phone]

www.innoliving.it

MADE IN CHINA

CE

1936