IH 30 - Inhaler BEURER - Free user manual and instructions

USER MANUAL IH 30 BEURER

• After opening the packaging, check that the Inhalator and accessories have no damage or defects. Otherwise contact your dealer immediately.

• Use the Inhalator only as specified, i.e. for aerosol therapy. All other use is improper and therefore dangerous. The manufacturer cannot be held responsible for damage caused by improper or incorrect usage.

• Use the Inhalator on frail persons and children only under supervision.

• The Inhalator and accessories must never be left in the unsupervised hands of children.

• Before using your Inhalator, ensure that the supply voltage stated on the power line adapter is the same as that of the local supply voltage.

• Use only the power line adapter supplied.

• Always use only pure water in the water tank. Other liquids may cause the Inhalator to be- come defective.

• The Inhalator must not be tilted or shaken during use. Otherwise, the medicament could be mixed with the water in the tank.

Keep the Inhalator away from your eyes during use. The medicament mist could cause injury.

• Never use the Inhalator when the water tank or medicament cup is empty.

• Always comply with the doctor´s instructions concerning the type of medicament to be used, the dosage and duration of inhalation.

• Do not operate the Inhalator in the presence of flammable gases.

• Never touch the power cord or power line adapter with wet hands - you could receive an electric shock.

• Comply with the cleaning instructions.

• Only one person should use the Inhalator in order to avoid cross infection.

• If you find that your Inhalator is not fuctioning correctly or is damaged, switch it off and dissconnect it from the power line adapter or battery. Then contact your authorized dealer. Only Beurer spare parts must be used. The Inhalator consists only of parts that can be repaired or exchanged by the authorized dealer/service agency.

• Batteries that are defective or no longer required should not be deposited in domestic wa- ste. Dispose of the fully discharged battery at disposal depots established for this purpo- se. You can fully discharge the battery yourself ba operating the Inhalator until its indicator lamp lights red or flashes. Power supply The Inhalator can be operated in two different ways:

1. With the power line adapter

The power line adapter is suitable for use in homes provided with a 230V supply voltage. Insert the smal plug of the power line adapter into the socket underneath the Inhalator. Then plug the power plug of the power line adapter into the socket outlet. The Inhalator is now ready to use.

2. With rechargeable battery

The battery allows you to use the Inhalator where no other power sources are available. Insert the small battery plug into the socket underneath the Inhalator. Its operating time lasts up to 30 min. If the indicator lamp lights red or ashes, this means that the battery is discharged and must be charged up. Use only the rechargeable battery supplied by the manufacturer. The use of other batteries can damage the Inhalator.12 Starting up The Inhalator must be thoroughly cleaned before first use. This also applies if the Inhala- tor has not been used for a long time (see ”cleaning”). Filling the water tank

1. Connect the Inhalator to the power line adapter or the battery.

2. Ensure that the Inhalator is switched off ( the indicator lamp must be not be lit, i.e. it must

neither flash green nor light up green!).

3. Remove the top cover from the Inhalator.

4. Fill the tank only with tap water or distilled water (20-30°C) otherwise you could damage

your Inhalator. We recommend that you boil the water beforehand. The correct filling level is between the two markings on the inside of the tank. If the water temperature is lower than 20°C, nebu- lization of the medicament will be considerably less than at the specified temperature. The warmer the water, the greater the degree of nebulization.

5. Empty the tank after every session and fill it again each time the Inhalator is used.

Filling the medicament cup

1. Place the medicament cup on the water tank.

2. Pour the medicament directly into the cup. Do not overfill the medicament cup! The filling

level is at max. 5 ml!

3. Use medicaments only under your doctor’s instructions and check the inhalation time

and quantity appropriate for you.

4. If the prescribed quantity of medicament is less than 2 ml, top it up to at least 4 ml with distil-

led water or isotonic saline solution! Viscous medicaments must also be diluted. In this case also, follow your doctor’s instructions.

5. Replace the top cover back on the Inhalator again and ensure that it snaps into place.

Stop using the medicament cup as soon as signs of wear appear at the tip (cracks, white marks). Do not use a medicament cup for more than three sessions. Using the Inhalator with accessories (optional) The Inhalator can be used both with and without a mask. It is advisable for children to use a mask. During the following procedures, take care not to tilt the Inhalator to prevent mixing of the water and medicament.

1. Make sure that the Inhalator is switched off.

2. Now push the short, white tube of the inhalation mask (with children the smaller mask) into

the open end of the extension tube.

3. Fit the extension tube into the aperture in the top cover by pushing the tube together slightly

at a smooth end, and push it into the aperture until a slight snap engagement can be heard. Operation Make sure that the Inhalator is in the vertical position before you switch it on and thus ensure that it operates correctly with maximum eectiveness.

1. Press the ON/OFF button to switch on the Inhalator. The indicator lamp lights up green.

2. Adjust the filter case at the back of the Inhalator to ensure the required amount of airflow. At

maximum setting, three air holes can be seen.

3. If desired, use the inhalation mask. We also recommend during use of the mask that you

breath in and out through your mouth in order to reach the bronchial system. If your nose is to be included, breath in through your nose and out through your mouth.13

4. Inhale the medicament prescribed by your doctor. The Inhalator is designed so that the

inhalation rate increases after a few minutes. It begins at a minimum.

5. When the mist is no longer constant, this indicates that the

medicament cup is empty. Inhale until no more mist is pro- duced or the Inhalator switches off (the Inhalator switches off automatically after 10 min. of use).

6. Switch off the Inhalator by pressing the ON/OFF button. The indicator lamp goes out. Unplug

the power plug of the power line adapter from the socket outlet and unplug the small plug from the socket underneath the Inhalator.

7. Empty the medicament and water residues (WARNING: HOT!) and clean the Inhalator as de-

scribed under ”Cleaning”. Allow the Inhalator to cool down for 30 minutes before re-use. Troubleshooting If problems still occur despite the following checks, send the Inhalator for repair to the address appropriate for you. Problem cause/solution The Inhalator does not react when the ON/ OFF button is pressed Check that the power line adapter/battery is connected to the Inhalator correctly. Check that the water tank has been properly lled. Check that the battery is properly charged. Low or no nebulization Make sure that the medicament cup is suf- ciently full (min. 2ml - max. 5ml) and is not broken. Check that the Inhalator under the medicament cup is clean. The fan is not operating correctly Check that the fan is securely and correctly connected to the motor shaft. Cleaning and storage Disconnect the power supply before cleaning. Do not immerse the Inhalator in water; it could be irreparably damaged. On each occasion after use, we advise you to clean the Inhalator as follows:

1. Remove the top cover, the medicament cup, air filter and filter case (pull down and out from

the rear protective sheath) and clean these parts with a damp cloth and a mild detergent or disinfectant according to the manufacturer’s instructions. Clean the extension tubing and inhalation masks in the same manner.

2. Clean the case with a damp, soft cloth and exclusively with water. Rinse the water tank tho-

roughly with clear water.

3. Use only a soft, dry cloth to clean the small fan and the air inflow under the rear cover. Only

the cover can be sterilized with boiling water. The Inhalator, the power line adapter and the rechargeable battery must not be exposed to direct sunlight, high temperatures or damp- ness. ca. 4ml max. 5ml max. 5ml app. 4ml at least 2ml14 Charging the battery

1. Plug the small plug of the power line adapter into the socket underneath the battery.

2. Now plug the power plug of the power line adapter into the socket outlet. The battery indica-

tor lamp lights. For first use and after a long period of non-use the charging time is approx. 24 hours, otherwise 10 - 12 hours according to the state of discharge of the battery.

3. Do not place the battery in metal containers, on any kind of metal or on wet surfaces. This

could cause the battery to be short-circuited with subsequent over-heating and possibly cause an explosion. Disposal Please dispose of the blanket in accordance with the directive 2002/96/EG – WEEE (Wa- ste Electrical and Electronic Equipment). If you have any queries, please refer to the local autho- rities responsible for waste disposal. Technical data: Inhalator Power input: approx. 10 Watt Ultrasonic frequency: 2.5 MH Nebulization rate:

0.2 to 0.7 ml/min according to medicament density

Particle size: 5 μm MMAD Med. cup capacity: max. 5 ml Automatic shutdown: after approx. 10 min. Storage conditions: -10°C to+50°C; 45% to 85% atmospheric humidity Operating conditions: +15°C to+30°C; 45% to 65% atmospheric humidity Dimensions: 65 x 50 x 140 mm Weight: approx. 185g Accessories: power line adapter, re-chargeable battery, adult/child mask, extension tube, protective bag, 5 medicament cup Re-chargeable battery: Type: Ni-Mh Rated voltage: 12V DC Charging current: 40 to 120 mA Charging time: initial charge min. 24 hrs. normal 10 to 12 hrs. normal 10 to 12 hrs. Rated capacity: 650 mAh Storage conditions: -18°C to +45°C Operating conditions: +15°C to +30°C Weight: 183g15 Replacement items: Designation REF Filter + medication container 071.00 Power line adapter Input voltage: 230V 50Hz Output voltage: 12V DC Rated current: 1.1A Rated power: 13.2 VA Protective class:

Note: If the unit is used outside of the specications, proper function is no longer guaranteed! We reserve the right to make technical changes to improve 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 measures in terms of electromagnetic tolerance. Note that portable and mobile RF communication equipment can aect this unit. More details can be requested from the stated Customer Service address or found at the end of the instructions for use. The unit conforms to the requirements of the European Directive 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 designated for private residential pur- poses. 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 notice any interference with other electrical devices, move the unit or connect it to a different socket.

Class A Voltage uctuations/icker emissions IEC 61000-3-3 Complies Table 2 For all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer’s declaration – electromagnetic immunity The IH30 is intended for use in the electromagnetic environment specied below. The customer or the user of the IH30 should assure that it is used in such an environment. IMMUNITY test IEC 60601 test level Compliance level Electromagnetic environment – guidance Electrostatic discharge (ESD)

± 6 kV contact ± 8 kV air ± 6 kV contact ± 8 kV air Floors should be wood, con- crete or ceramic tile. If oors are covered with synthetic material, the relative humidity should be at least 30 %. Electrical fast transi- ent/burst

±2 kV for power sup- ply lines ±2 kV for power sup- ply lines Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 ±1 kV line(s) and neu- tral ±1 kV line(s) and neu- tral 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 IEC 61000-4-11 <5 % U

) for 5s Mains power quality should be that of a typical commercial or hospital environment. If the user of the IH30 requires continued operation during power mains interruptions, it is recommen- ded that the IH30 be powered from an uninterruptible power supply or a battery. Power frequency (50/60 Hz) magnetic eld IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic elds should be at levels cha- racteristic of a typical location in a typical commercial or hos- pital environment. NOTE: U

is the a.c. mains voltage prior to application of the test level.67 Table 3 For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacturer’s declaration – electromagnetic immunity The IH30 is intended for use in the electromagnetic environment specied below. The customer or the user of the IH30 should assure that it is used in such an environment. IMMUNITY test IEC 60601 test level Compliance level Electromagnetic environment – guidance Conducted RF

3 V r m s 150 kHz to 80 MHz 3 V / m 80 MHz to

3 Vrms 3 V / m Portable and mobile RF communications equipment should be used no closer to any part of the IH30 , inclu- ding cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d = 1.2 d = 1.2 80 MHz to 800 MHz d = 2.3 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from xed RF transmitters, as determined by an electromagnetic site survey,

should be less than the compliance level in each frequency range.

Interference may occur in the vicinity of equipment mar- ked 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 aected by absorption and reection from structures, objects and people.

Field strengths from xed 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 xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the IH30 is used exceeds the applicable RF compliance level above, the IH30 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the IH30.

Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.68 754.303-0912 Irrtum und Änderungen vorbehalten Table 4 For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the IH30 The IH30 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the IH30 can help electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the IH30 as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W) Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz d = 1.2 80 MHz to 800 MHz d = 1.2 800 MHz to 2.5 GHz d = 2.3

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined 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 aected by absorption and reection from structures, objects and people.