SIH 21 - Inhaler SANITAS - Free user manual and instructions

USER MANUAL SIH 21 SANITAS

• These instructions for use

1. Getting to know your instrument .......................15

4. Description of device and accessories .............17

The following symbols appear in these instructions. Warning Warning instruction indicating a risk of injury or damage to health. Important Safety note indicating possible damage to the unit/accessory. Note Note on important information. The following symbols are used on the packaging and on the nameplate of the device and accessories. Type BF applied part Read the instructions for use Device in protection class 2

Serial number 30 ON / 30 OFF 30 minute operation, followed by a 30 minute break before operation continues. Keep dry.

1. Getting to know your instrument

Dear valued customer Please read these instructions for use carefully and keep them for later use, be sure to make them ac- cessible to other users and observe the information they contain. Area of application This nebuliser is a device used for the nebulisation of liquids and liquid medication (aerosols) and for the treatment of the upper and lower respiratory tract. The nebulisation and inhalation of medication prescri- bed or recommended by a doctor can prevent against diseases of the respiratory tract, treat the side effects of these disorders and accelerate healing. For more information on possible applications, consult your doctor or pharmacist. The device is suitable for inhalation at home. Medicines should only be inhaled when instructed by a doctor. Inhalation should be performed in a calm and relaxed atmosphere. Inhale slowly and deeply to enable the medicine to reach the small bronchi deep into the lungs. Exhale normally.

2. Signs and symbols16

3. Safety information and warnings

Before use, ensure that there is no visible damage to the unit or accessories. When in doubt, do not use the unit and contact your dealer or the customer service address provided.

In the event of device faults, please see Chapter "10. Troubleshooting".

Using the unit is not a substitute for consultation with or treatment from a physician. Whenever you have any pain or illness, always contact your physician first.

If you have health concerns of any kind, contact your general practitioner!

Always follow your doctor’s instructions regarding the type of medicine to be used and the dose, fre- quency, and duration of inhalation.

Only use medicines that have been prescribed or recommended by your doctor or pharmacist. Please note: For treatment, only use parts indicated by your doc- tor according to the particular diagnosis.

• Check whether there are contraindications for use with the usual systems for aerosol therapy on the medication instruction leaflet.

If the unit does not function correctly or if you begin to feel unwell or feel pain, stop using the unit imme

During use, hold the unit away from the eyes, as some nebulised medicines may cause damage to the eyes.

Do not operate the unit in the presence of flammable gases.

This device is not intended to be used by children or persons with restricted physical, sensory (e.g. insensitivity to pain) or mental abilities or persons lacking in the required experience or knowledge for safe operation of the device, unless supervised or instructed by a person responsible for their safety.

The device must be switched off and the plug pulled out before every cleaning and/or maintenance pro- cedure.

Keep children away from packaging materials (risk of suffocation).

To avoid the risk of entanglement and strangulation, store cables and air lines out of the reach of small children.

Do not use attachments that are not recommended by the manufacturer.

Connect the unit only to the mains voltage listed on the type plate.

Do not dip the unit into water and do not use it in wet rooms. Do not allow any liquid to penetrate the unit.

Protect the unit from strong impacts.

Never touch the mains cable with wet hands, this can cause an electric shock.

Do not pull the mains plug from the socket by the cord.

Do not pinch or bend the mains cable, pull it over sharp objects, or allow it to hang freely, and protect it against sources of heat.

We recommend that the power cable is completely unrolled to avoid dangerous overheating.

If the mains cable or housing is damaged, contact our customer service department or your local deal- er.

Opening the unit carries a risk of electric shock. Dis- connection from the mains supply is only guaranteed if the mains plug has been removed from the socket.

Do not use the unit if it has fallen or been dropped on the floor, been exposed to extreme humidity or is otherwise damaged. In case of doubt, contact our customer service department or your local dealer.

The SIH 21 nebuliser must only be used with suit- able atomisers and with the appropriate accesso- ries. The use of other atomisers and accessories can impair therapeutic efficiency and may dam

age the device. Important

Power cuts, sudden faults or other unfavourable conditions may render the unit unusable. You are therefore recommended to keep a spare device or replacement medicine (as agreed with the doctor).

If adapters or extensions are required, these must comply with the applicable safety regulations. The electrical capacity and the maximum capacity spec- ified on the adapter must not be exceeded.

The unit and the mains cable must be stored away from sources of heat.

Do not use the unit in a room in which a spray has previously been used. If this is the case, ventilate the room before commencing treatment.

Do not allow any objects to enter or obstruct the ventilation openings.

Do not use the device if you notice an unusual noise.

For hygiene reasons, each user must use his own accessories.

Always disconnect from the mains after use.17

4. Description of device and accessories

1 Mains cable 2 Lid 3 On/off switch 4 Compartment for accessories 5 Filter cap with filter 6 Hose connection 7 Holder for atomiser

Store the device in a location protected against en- vironmental influences. The device must be stored in the specified ambient conditions. FUSE

The device contains an overload protection fuse. This must only be changed by authorised specialist personnel. General notes Important

for its intended purpose (aerosol inhalation) and in the manner described in these instructions for use.

In acute emergencies, first aid takes priority.

Apart from the medication, use only distilled water or a saline solution in the unit. Other liquids may cause defects to the nebuliser or atomiser.

This unit is not intended for commercial or clinical use, but only for individual, private household use! Before using the unit for the first time Important

Before you use the unit for the first time, remove all packaging materials.

Protect the unit against dust, dirt and moisture. Never cover the unit during operation.

Do not use the unit in very dusty environments.

Switch the unit off immediately if it is defective or malfunctioning.

The manufacturer shall not be held liable for damage or injuries caused by improper or incorrect use. Repairs Note

Never open or attempt to repair the unit yourself, as otherwise proper function is no longer guaranteed. Failure to observe this regulation shall void the war

If you need to have the unit repaired, contact cus- tomer service or an authorised dealer.18 Overview of atomiser and accessories 8 Compressed air hose 9 Atomiser 10 Nozzle attachment 11 Medicine container 12 Mouthpiece 13 Adult mask 14 Child mask 15 Replacement filter

Setup Remove the unit from the packaging. Place it on a flat surface. Ensure that the ventilation slits are free. Fold open the lid [2] to access the accessories. Before using the unit for the first time Note

The atomiser and accessories must be cleaned and disinfected before they are used for the first time. For information about this, see “Cleaning and disinfec- tion” on page 20.

Attach the compressed-air hose [8] at the bottom of the medicine container [11].

Connect the other end of the hose [8] to the hose connector [6] on the nebuliser by lightly turning it. Mains connection Connect the unit only to the mains voltage listed on the type plate.

Insert the mains cable plug [1] into a suitable socket.

Push the plug completely into the mains socket. Note

Ensure that there is a socket near to where the unit will stand.

Lay the mains cable in such a way that no one can trip over it.

To disconnect the nebuliser from the mains after use, first switch off the device and then remove the plug from the socket.19

For hygiene reasons, the atomiser [9] and the ac

cessories must be cleaned after each treatment and disinfected after the last treatment of the day.

The accessories may be used only by one person; use by several people is not recommended.

If several different medicines are to be inhaled in succession during therapeutic use, the atomiser [9] must be rinsed under warm tap water after each use. For information about this, see “Cleaning and disinfection” on page 20.

Follow the instructions for changing the filter con- tained in these instructions.

Before each use, check that the hose connections on the nebuliser [6] and the atomiser [9] are tight.

Before use, check that the device is functioning cor- rectly. To do this, switch on the nebuliser (including the connected atomiser, but without any medication) for a short time. If the atomiser [9] expels air, the device is functioning correctly.

1. Inserting the nozzle attachment

To open the atomiser [9], twist the upper section anti-clockwise against the medicine container [11]. Place the nozzle attachment [10] in the medicine container [11].

Ensure that the cone for administering medication fits well on the cone for the air duct inside the nebu- liser.

Use medication only on the advice of a physician, and check the appropriate inhala- tion duration and quantity for your needs.

If the required volume of medication is less than 2 ml, top up this quantity to at least 4 ml using an isotonic saline solution. Viscous medicines may also require dilution. Always follow the instructions of your doc

To close the atomiser [9], twist the upper section clockwise against the medicine container [11]. En- sure the parts are connected correctly.

4. Connecting the accessories to the atomiser

onnect the required accessory part (mouthpiece [12], adult mask [13] or child mask [14]) to the atom- iser [9]. Note The most effective form of nebulisation is by using the mouthpiece. Nebulisation using a mask is only recom- mended if it is not possible to use a mouthpiece (e.g. for children who are not yet able to inhale medication using a mouthpiece).

Before commencing treatment, pull the atomiser upwards out of its holder [7].

A flow of spray from the atomiser indicates that the device is functioning properly.

When inhaling, sit upright and relaxed at a table and not in an armchair to avoid compressing the airways and therefore impairing the effectiveness of the treat- ment.

Inhale the nebulised medicine deeply. Important The device is not suitable for continuous operation; after 30 minutes of operation it must be switched off for 30 minutes. Note During treatment, hold the atomiser straight (vertical), otherwise the atomisation does not work and correct function cannot be guaranteed. Important Essential oils, cough medicines, solutions designed for gargling, and drops for application to the skin or for use in steam baths are wholly unsuitable for inha- lation using a nebuliser. These substances are often highly viscous and can impair the correct function of the device and hence affect the effectiveness of its application in the long term. In the case of oversensitivity of the bronchial system, medicines containing essential oils can sometimes cause acute bronchiospasm (a sudden, cramp-like tightening of the bronchi accompanied by breathless- ness). Always ask your doctor or pharmacist for advice!20

6. End of inhalation

If the spray is only output sporadically or if the noise changes during inhalation, you can end the treatment.

• Switch off the nebuliser after treatment using the on/ off switch [3] and disconnect it from the mains.

After use, replace the atomiser [9] in its holder [7].

In normal operating conditions, the air filter must be replaced after approx. 500 operating hours or one year. Please check the air filter regularly (after 10-12 nebuli- sation procedures). If the filter is very contaminated or blocked, replace the used filter. If the filter has become wet, it must also be replaced with a new one. Caution

Do not try to clean and re-use the used filter!

Only use original filters supplied by the manufacturer. Otherwise, your nebuliser may become damaged or effective therapy can no longer be guaranteed.

Do not repair or maintain the air filter while it is in use.

Never operate the device without a filter. To replace the filter, proceed as follows: Caution

First switch off the unit and unplug it.

Allow the unit to cool down.

1. Remove filter cap [5] upwards.

Note If the filter remains in the unit when the cap is removed, remove the filter from the unit using tweezers or similar.

2. Replace the filter cap [5] containing the new filter.

3. Check that the filter cap is firmly in place.

8. Cleaning and disinfection

Atomiser and accessories Warning Observe the following hygiene instructions in order to avoid any health risks.

The atomiser [9] and accessories are intended for multiple use. Please note that cleaning requirements differ according to the different application areas. Notes:

The atomiser and accessories must not be mechan- ically cleaned with brushes or similar as this can cause irreparable damage and the success of the treatment can no longer be guaranteed.

For additional requirements regarding the necessary hygienic preparations (hand washing, handling of medicines or inhalation solutions) in high-risk groups (e.g. cystic fibrosis patients), contact your doctor.

Ensure that all parts are properly dried following all cleaning and disinfection. Residual moisture or water droplets can result in an increased risk of bacterial growth. Preparation

Directly following each treatment, all parts of the atomiser [9] and any accessories used must be cleaned of medicine residues and contamination.

To do this, dismantle the atomiser [9] into its com- ponent parts.

Remove the mouthpiece [12] from the atomiser.

Dismantle the atomiser by twisting the upper section anti-clockwise against the medicine container [11].

Remove the nozzle attachment [10] from the medi- cine container [11].

The nebuliser is later reassembled in the reverse order. Cleaning Important Before you clean the unit, always switch it off, unplug it and let it cool off.21 The atomiser and the used accessories such as the mouthpiece, mask, nozzle attachment, etc. must be washed with hot but not boiling water after each use. Carefully dry all components using a soft cloth. Once all components are fully dry, reassemble the atomiser and place the components in a dry, sealed container or carry out disinfection. When cleaning, ensure that all residues are removed. Never use any substances that may be poisonous when in contact with the skin or mucous membranes, or when swallowed or inhaled. Use a soft, dry cloth and non-abrasive cleaning pro- ducts to clean the device. Do not use abrasive detergents and never immerse the unit in water. Important

Ensure that no water penetrates inside the unit!

Do not put the device or accessories in a dishwasher.

Do not touch the unit with wet hands while it is plugged in; do not allow any water to be sprayed onto the unit. The unit must be operated only when it is completely dry.

Do not spray any liquids into the ventilation slots. Any liquid that penetrates into the unit can damage the electrical parts or other components of the nebuliser and impair the function of the device. Condensation, care of the hose Depending on the environmental conditions, con- densation may collect in the hose. To prevent against bacterial growth and to ensure effective therapeutic use, this moisture must always be removed. To remove moisture from the hose, proceed as follows:

Leave the hose plugged into the nebuliser [6].

Run the nebuliser until all the moisture has been displaced by the flow of air.

In the event of significant contamination, replace the hose. Disinfection Follow the steps listed below carefully in order to disin- fect your atomiser and the accessories. It is advisable to disinfect the individual components after the last time they are used each day at the latest. (For disinfection, you will simply require a small amount of clear vinegar and distilled water).

• First clean the atomiser and the accessories as described under “Cleaning”.

Place the disassembled nebuliser and mouthpiece in boiling water for five minutes.

For the remaining accessories, use a vinegar solution consisting of ¼ vinegar and ¾ distilled water. Make sure that the volume is sufficient to fully submerge the parts in the solution.

• Leave the components in the vinegar solution for 30 minutes.

Rinse the parts with water and dry carefully with a soft cloth. Important Do not boil or autoclave the masks and air hose.

Once all components are fully dry, reassemble the atomiser and place the components in a dry, sealed container. Note Ensure that all parts are thoroughly dried during, and in particular after cleaning, otherwise there is an in- creased risk of bacterial growth. Sterilisation Use the cold sterilisation solutions according to the manufacturer's instructions. Drying

Place the individual components on a dry, clean and absorbent surface and allow to dry completely (for at least 4 hours). Material resistance

As with all plastic components, frequent use and cleaning of the atomiser and the accessories can lead to a certain amount of wear. Over time, this can alter the aerosol properties and may eventually affect the efficiency of therapy. We therefore recommend that you replace the atomiser once a year.

When choosing a cleaning or disinfecting agent, note the following: Only use mild cleaning or disinfectant agents in the quantities recommended by the man

Do not store the nebuliser in a damp atmosphere (e.g. in the bathroom) or transport it together with damp objects.

Store and transport the nebuliser away from direct sunlight.

The accessories can be safely stored in the acces- sories compartment [4]. Store the device in a dry place, if possible in its original packaging.22

In the interest of environmental protection, do not dis- pose of the device in household waste. Please dispose of the device in accordance wi

th EC Directive – WEEE (Waste Electrical and Electronic Equipment). If you have any queries, please contact the ap

prpriate local authorities.

1. Too much or too little medicine in the atomiser.

Minimum: 2 ml, Maximum: 8 ml.

2. Check that the nozzles are not blocked If necessary, clean the nozzle (e.g.

by rinsing). Use the atomiser again. CAUTION: Only poke implements through the fine holes from the underside of the nozzle.

3. The atomiser is not held in an upright position.

4. The medicine solution is unsuitable for nebulising (e.g. too thick). The

medicine solution should be specified by the doctor. Output is too low. Hose kinked, filter blocked, too much inhalation solution. Which medicines are suitable for inhalation? Consult your doctor. Essentially all medicines that are suitable and approved for device-based inhalation can be inhaled. Some inhalation solution remains in the atomiser. This is normal and occurs for technical reasons. Stop inhalation if you hear a notable difference in the noise of the atomiser. What special steps should be taken for babies and children?

1. In babies, the mask should cover the mouth and nose to guarantee effec

2. In children, the mask should also cover the mouth and nose. Nebulisation

next to a sleeping person is not suitable because insufficient medicine reaches the lungs. Note: Children should only use the device with help and under supervision of an adult. Never leave a child alone with the nebuliser. Inhalation with the mask takes longer. This is for technical reasons. Less medicine is inhaled per breath through the mask holes than using the mouthpiece. The aerosol is mixed with ambi

ent air through the holes in the mask. Why do I need to replace the atomiser at regular intervals? There are two reasons for this:

1. To guarantee a therapeutically effective particle spectrum, the nozzle

holes should not exceed a certain diameter. Due to the thermal and mechanical stresses, the plastic is subjected to a certain amount of wear. The nozzle attachment [10] is particularly susceptible to this wear. This can also cause changes to the droplet composition of the aerosol, which has a direct effect on the effectiveness of the treatment.

2. You are also recommended to replace the atomiser on a regular basis for

hygiene reasons. Does each person need their own atomiser? This is absolutely necessary for hygiene reasons.23

11. Technical specifi cations

Model SIH 21 Type SIH 21/2 Dimensions (WxHxD) 300 x 180 x 100 mm Weight 1.65 kg Working pres- sure Approx. 0.8 to 1.45 bar Atomiser filling volume Max. 8 ml Min. 2 ml Medication flow rate Approx. 0.4ml/min. Sound pressure max. 52 dBA (acc. to DIN EN 13544-1 section 26) Mains connection 230 V~; 50 Hz; 230 VA UK: 240 V~; 50 Hz; 240 VA Operating conditions Temperature: +10 °C – +40 °C Relative humidity: 10% – 95% Storage and transport conditions Temperature: 0 °C – +60 °C Relative humidity: 10% – 95% Atmospheric pressure: 500 – 1060 hPa Aerosol Properties Flow: 5.31 l/min Aerosol delivery: 0.171 ml Aerosol delivery rate: 0.082 ml/min Particle size (MMAD): 3.16 µm Subject to technical modifications. Measurements were performed using a sodium fluoride solution with a "Next Generation Impactor" (NGI). All measurements were obtained with a sodium chlo- ride solution using a laser diffraction method. This diagram may not be applicable for suspensions or highly viscous medicines. More information can be obtained from the relevant medicine manufacturer. Spare parts SIH 21 year pack Mouthpiece, adult/children's mask, atomiser, compressed air hose, filters REF

Note If the unit is used outside of the specifications, proper function is no longer guaranteed! We reserve the right to make technical changes to im- prove and further develop the product. This device and its accessories comply with European standards EN60601-1 and EN60601-1-2, as well as EN13544-1, and is subject to special safety meas- ures in terms of electromagnetic tolerance. Note that portable and mobile RF communication equipment can affect this unit. For detailed information, contact customer service at the address provided. The unit conforms to the requirements of the European Direc- tive for Medical Products 93/42/EC, the MPG (German Medical units Act). ELECTROMAGNETIC COMPATIBILITY

The device complies with current specifications with regard to electromagnetic compatibility and is suitable for use in all premises, including those des- ignated for private residential purposes. The radio frequency emissions of the device are extremely low and in all probability do not cause any interference with other devices in the proximity.

It is recommended that you do not place the device on top of or close to other devices. Should you no- tice any interference with other electrical devices, move the unit or connect it to a different socket.

Minimum: 2ml, Maximum: 8ml.

Guidance and manufacturer’s declaration - electromagnetic emissions The SIH21/2 is intended for use in the electromagnetic environment specified below. The customer or the user of the SIH21/2 should assure that it is used in such an environment Emissions Compliance Electromagnetic environment – guidance RF emissions CISPR 11 Group 1 The SIH21/2 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class B The SIH21/2 is suitable for use in all establish

ments other than domestic, and may be used in domestic establishments and those direct- ly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded:

Warning: This equipment/system is intended

for use by healthcare professionals only. This equipment/ system may cause radio interfe- rence or may disrupt the operation of nearby equipment. It may be necessary to take mitigati- on measures, such as re-orienting or relocating the SIH21/2 or shielding the location. Harmonic emissions

Class A Voltage fluctuations/flicker emissions

Complies60 Guidance and manufacturer’s declaration – electromagnetic immunity The SIH21/2 is intended for use in the electromagnetic environment specified below. The customer or the user of the SIH21/2 should assure that it is used in such an environment Immunity test EN 60601 test level Compliance level Electromagnetic environment – gui- dance Electrostatic discharge (ESD)

±6 kV contact ±8 kV air ±6 kV contact ±8 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humi- dity should be at least 30 % Electrical fast transient/burst

±2 kV for power sup- ply lines ±1 kV for input/output lines ±2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment. The electrical fast transient burst (EFT) is generated by the switching of inductive loads. Separation between the equipment and other loads shall be considered before installation. Mains filter is required, if necessary. Surge

±1 kV line(s) to line(s) ±2 kV line(s) to earth ±1 kV line(s) to line(s) Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines

for 5s Mains power quality should be that of a typical commercial or hospital en- vironment. If the user of the SIH21/2 requires continued operation during power mains interruptions, it is re- commended the SIH21/2 be powered from an uninterruptible power supply or a battery. Power frequency (50/60Hz) magnetic field

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commer

cial or hospital environment. NOTE U

is the a.c. mains voltage prior to application of the test level61 Guidance and manufacturer’s declaration – electromagnetic immunity The SIH21/2 is intended for use in the electromagnetic environment specified below. The customer or the user of the SIH21/2 should assure that it is used in such an environment Immunity test EN 60601 test level Compliance level Electromagnetic environment – guidance Conducted RF

3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to

3 V 3 V/m Portable and mobile RF communications equipment should be used no closer to any part of the SIH21/2, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recom- mended separation distance in metres (m) Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equip- ment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SIH21/2 is used exceeds the applicable RF compliance level above, the SIH21/2 should be observed to verify normal opera

tion. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the SIH21/2.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.62 Recommended separation distances between portable and mobile RF communications equipment and the SIH21/2 The SIH21/2 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SIH21/2 can help prevent electromagnetic interference by maintai- ning a minimum distance between portable and mobile RF communications equipment (transmitters) and the SIH21/2 as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter

Separation distance according to frequency of transmitter

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.6364 751.869-0715 Irrtum und Änderung vorbehalten