strack Boso Medisol Compact Nebuliser Instruction Manual

strack Boso Medisol Compact Nebuliser Instruction Manual

GETTING TO KNOW YOUR DEVICE

COMPONENTS

1. Compressor housing

2. Air outlet

3. Battery level indicators

4. Filter compartment

5. Micro USB port

6. ON/OFF button

7. Switching on LED
   

8. Nebulizer
   

9. Mouthpiece
   

10. Air tube
    

11. Adult mask
    

12. Pediatric mask
    

13. Replacement filters
    

14. Nosepiece
    

15. Micro USB cable
    

16. Power adapter
    

17. Storage bag
    

WARNINGS AND SAFETY NOTES

boso medisol compact is an aerosol therapy system indicated for home use.

WARNINGS

1. Use the device only as described in this manual, therefore as an aerosol therapy system, and follow the directions provided by your physician. Any use different from the intended one is to be considered improper and hence dangerous; the manufacturer cannot be held liable for
   any damage caused by improper, incorrect and/or unreasonable use, or if the equipment is connected to electrical installations which do not comply with current safety regulations.

2. Keep this manual for future reference.

3. Do not use the device in the presence of any anaesthetic mixture inflammable with oxygen or nitrogen protoxide.

4. The correct operation of the device may be affected by electromagnetic interferences that exceed the limits indicated by the European standards in force. In case this device interferes with other electrical devices, move it and plug it to a different power socket.

5. In case of failure and/or malfunction of the device, read the “POSSIBLE PROBLEMS AND HOW TO SOLVE THEM” section. Do not tamper with or open the compressor’s housing.

6. For repairs address only to a technical service centre authorised by the manufacturer and always request the use of original spare parts. Failure to comply with the above mentioned indications can compromise the safety of the device.

7. Comply with the safety regulations concerning the electrical devices and in particular:

   • use only original accessories and components;
   • never immerse the device in water;
   • never wet the device;
   • never touch the device with wet or moisty hands;
   • do not leave the device exposed to atmospheric agents;
   • this device is not intended for use by children or people with restricted physical, sensory (e.g. reduced sensitivity to pain, visual impairment) or mental skills or a lack of experience and/or lack of knowledge, unless they are supervised by a person who is responsible for their safety or are instructed by such a person in how to use the device.
   • do not pull the power cord or the device itself to unplug it from the power socket;

8. The device operates on batteries. You can also use the device plugged to the mains.

   • Protect batteries from excessive heat.
   • Risk of explosion! Never throw batteries into a fire.
   • Do not disassemble, split or crush the rechargeable batteries.
   • Only use chargers specified in the instructions for use.
   • Batteries must be charged correctly prior to use. The instructions from the manufacturer and the specifications in these instructions for use regarding correct charging must be observed at all times.
   • Fully charge the battery prior to initial use.
   • In order to achieve a long as possible battery service life, fully charge the battery at least twice per year.

9. Before connecting the power plug, ensure that the electrical data shown on the rating plate on the bottom of the unit, matches the nominal data of the mains.

10. If the plug supplied with the appliance is not compatible with the mains electricity socket, contact qualified staff to replace the plug with a suitable one. Mainly, it is not advisable to use adaptors, either single or multiple, and/or extension leads. If the use thereof is necessary, you must use types conform to safety standards, being however careful not to exceed the maximum specified power limits that are written on the adaptors and the extension leads.

11. Never leave the appliance plugged in when not used: unplug the device form the mains outlet when the device is not in use or has fully charged.

12. The installation has to be carried out by qualified personnel following the instructions of the manufacturer. Incorrect installation can cause damage to people, animals or property, for which the manufacturer cannot be deemed liable.

13. The USB cable and the power supply adapter of this device must not be replaced by the user. In case of damage, have them replaced by a service centre authorised by the manufacturer.

14. It is recommended to fully extend the power cord, throughout its entire length, to avoid dangerous overheating.

15. Before performing any cleaning and/or maintenance operation, switch off the device and unplug it.

16. Some parts of the device are so small that they can be swallowed by children; keep the device out of the reach of children.

17. Should you decide not to use the device, it is recommended to dispose it of in accordance with the current regulations.

18. Make sure to:

    • use this device only with medicines prescribed by your doctor;
    • carry out the treatment only using the accessory indicated by your doctor depending on the pathology;
    • use the nosepiece accessory only if expressly indicated by your doctor and be careful to NEVER introduce the bifurcations in the nose, but only bring them as close as possible to it.
      Important
      Essential oils, cough syrups, gargling solutions and drops to be used as a rub or in a steam bath are wholly unsuitable for inhalation using a nebuliser. These additives are often viscous and can impair the correct functioning of the device and therefore the effectiveness of the application in the long term. For individuals with a hypersensitive bronchial system, medications containing essential oils may under certain conditions cause an acute bronchospasm (a sudden cramp-like restriction of the bronchi with shortness of breath). Consult your doctor or pharmacist in relation to this matter.

19. Check in the medicine package leaflet for any contraindications for use with common aerosol therapy systems.

20. Do not place the device so that it is difficult to unplug.

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

22. To prevent strangulation and suffocation, keep the power cord and the air hose out of the reach of children.

23. The accessories are to be used for a single patient. It is not recommended to use them on several patients.

INSTRUCTIONS FOR USE

The device must be checked before each use in order to identify any malfunctions and/or damage caused during transportation and/or storage.During inhalation, sit upright and relaxed to avoid compressing the airways and impairing treatment effectiveness.
Ensure you are calm and relaxed when inhaling the medication and breathe slowly and deeply to ensure that the medication reaches right down to the fine, lower bronchi. Breathe out normally.

1. After unpacking the device, check it for visible damages or defects; pay particular attention to cracks in the plastic housing, which may expose electrical components. Check if the accessories are intact.

2. Before using the device, proceed with the cleaning operations as described in the chapter «CLEANING AND MAINTENANCE».

3. Open the nebulizer by turning counterclockwise the top.

4. Make sure that the medicine conduction cone is properly fitted on the air conduction cone inside the nebulizer.

5. Pour into the nebuliser the amount of medicine indicated by your doctor.
   

6. Close the nebulizer by turning clockwise the two parts making sure that they are properly sealed.

7. Connect one end of the air tube to the dedicated outlet at the bottom of the nebulizer and the other end to the air outlet on the device.
   
   

8. Connect the required accessory part (mouthpiece, adult mask, child mask or nosepiece) to the nebulizer.
   

9. To start treatment, press the “I/O” switch and make sure the orange LED above the power button is steadily lit.
   

10. The battery inside the device is indicated by the blue LED below the  battery icon.
    

11. If the battery is empty, the blue LEDs are not lit and the orange LED above the “I/O” switch flashes.
    

12. When the battery is empty, plug the device to the mains outlet and wait a few minutes before you switch it on.
    

13. While charging, the blue LED flashes.

14. In case of prolonged non-use, we recommend that you charge the battery completely every 3 months to ensure maximum performance of the same.
    CAUTION! The device is not suitable for continuous operation; after 30 minutes of operation it must be switched off for 30 minutes.

15. Inhale the aerosol solution using the prescribed accessory.
    Note
    The most effective form of nebulisation is by using the mouthpiece. Nebulisation using a mask is only recommended if it is not possible to use a mouthpiece (e.g. for children who are not yet able to inhale using a mouthpiece). When using a mask to inhale, take care to ensure the mask fits well and the eyes are unobstructed.

16. Once you have finished the treatment, switch the appliance off by pressing the “I/O” switch.

17. Clean the nebulizer and its accessories following the steps in the «CLEANING AND MAINTENANCE» section.

18. The device requires no calibration.

19. Tampering with the device is absolutely forbidden.

20. Once it has been properly prepared, the device can be used again. Preparation involves replacing all the accessories, including the atomiser and air filter, and disinfecting the surface of the device using a standard disinfectant. Please note that all accessories should be replaced if the device is used by more than one person.

CLEANING AND MAINTENANCE

The device is maintenance-free.

CAUTION!
During cleaning operations, make sure the internal parts of the device are not in contact with liquids and that the power plug is disconnected.

• The device must be cleaned with a soft dry cloth and nonabrasive cleaners.

Cleaning and disinfection of the accessories
Follow the directions on cleaning and disinfection of the accessories as they are critical to product performance and therapy success.

Upon first use and at the end of each application:

• Disassemble the nebulizer by turning the top counterclockwise and remove the medication conduction cone.
• Wash the components of the disassembled nebulizer, the mouthpiece, and nosepiece with tap water.
• Finally, dip them in boiling water for 5 minutes.
• Reassemble all parts of the nebulizer and connect it to the air outlet and switch on the device for 10-15 minutes.

Do not boil or autoclave the air hose and the masks.

Disinfection:

Cold disinfecting solutions can be used, instead of boiling water, according to manufacturer’s instructions.

NEBULIZER REPLACEMENT

The nebulizer must be replaced after a long period of inactivity, in case it shows deformations or breakings, or when the nebulizer nozzle is obstructed by dry medicine, dust, etc. boso recommends to replace the nebulizer after a period between 6 months and 1 year, depending on the usage.

Use original nebulizers only.

The device is only compatible with the boso medisol compact Accessories kit.

FILTER REPLACEMENT

Under normal usage conditions the air filter must be replaced every 100 operating hours or every 12 months at the latest. boso recommends to periodically check the air filter (10 – 12 treatments) and, if the filter shows a grey or brown colour or is wet, replace it. Remove the filter (Pic. A-4) and replace it with a new one. Do not attempt to clean the filter to reuse it.

Only use original filters.
Do not use the device without the filter.

POSSIBLE PROBLEMS AND HOW TO SOLVE THEM

• Make sure the battery is charged (if empty, charge it as indicated in this owner’s manual and switch the device on after 5 minutes.
• Make sure the plug is properly inserted in the power outlet.

The device does not nebulize or nebulizes weakly.|

• Make sure the air hose fittings are properly inserted in the compressor and the nebulizer connections.
• Make sure the nebulizer is not empty or that it has been filled with the correct amount of medication (MAX. 6 ml).
• Make sure that the nebulizer nozzle is not clogged.

The device is noisy.|

• Make sure that the filter is mounted properly

If the device is not able to function properly again, please contact boso Customer Services (see 8. Warranty).

MAINTENANCE AND REPAIRS

In case of damage, please contact boso Customer Services (see 8. Warranty). Never open the device. The device has no user-serviceable parts within and does not need internal maintenance or lubrication.

TECHNICAL SPECIFICATIONS

• Model: boso medisol compact
• Electrical power supply: Internal lithium polymer (Li-Pol) battery 3.7 V; 2570 mAh
• Power supply adapter: Input: 100-240 V AC; 50-60 Hz; 0.5 A
• Output: 5V DC; 2A
• Minimum filling volume: 2 ml
• Maximum filling volume: 6 ml
• Nebulization rate: 0.25 ml/min
• Operating Pressure: 0.25 ~ 0.5 bar
• Weight: 200 g
• Dimensions: 45 x 53 x 98 mm
• Noise level: 45 dBA
• Expected service life of the   device: 400 hours
• Material: Atomiser (PP), mouthpiece (PP), nosepiece (PP), masks (PVC)
• Residual volume: approx. 0.7 ml

1. Class II device referred to protection against electric shock.
2. Nebulizer, mouthpiece, masks and nosepiece are type BF applied parts.
3. Device for intermittent use (30 min on – 30 min off).
4. Device not suitable for anaesthesia and lung ventilation systems.
5. Device not suitable for use in the presence of any anaesthetic mixture inflammable with oxygen or nitrogen protoxide.

Technical specifications subject to change without notice.
The internal batteries cannot be replaced by the user.

AEROSOL CHARACTERISTICS IN ACCORDANCE WITH REGULATION EN 13544-1 APPENDIX CC

• Aerosol output: 0.15 ml
• Aerosol output rate: 0.03 ml/min
• Particle size (MMAD): 4.12 µm

Particle size diagram

Standards applied:

This device and its accessories comply with the European standards
EN60601-1, EN60601-1-2 (CISPR 11, IEC61000-3-2,
IEC61000-3-3, IEC61000-4-2, IEC61000-4-3, IEC61000-4-4,
EC61000-4-5, IEC61000-4-6, IEC61000-4-7, IEC61000-4-8,
IEC61000-4-11) and EN13544-1 and are subject to particular precautions with regard to electromagnetic compatibility.
This device meets the requirements of European Directive 93/42/EEC for medical devices, as well as those of the Medizinproduktegesetz (German Medical Devices Act).

Notes on electromagnetic compatibility

• The device is suitable for use in all environments listed in these instructions for use, including domestic environments.
• The use of the device may be limited in the presence of electromagnetic disturbances. This could result in issues such as error messages or the failure of the display/device.
• Avoid using this device directly next to other devices or stacked on top of other devices, as this could lead to faulty operation. If, however, it is necessary to use the device in the manner stated, this device as well as the other devices must be monitored to ensure they are working properly.
• The use of accessories other than those specified or provided by the manufacturer of this device can lead to an increase in electromagnetic emissions or a decrease in the device’s electromagnetic immunity; this can result in faulty operation.

ENVIRONMENTAL CONDITIONS

Storage and Transport

• Temperature: MIN -20 °C – MAX +60 °C
• Humidity: MIN 10% RH – MAX 95% RH
• Atmospheric pressure: 700 hPa – 1060 hPa

Operation

• Temperature: MIN +10 °C – MAX +40 °C
• Humidity: MIN 10% RH – MAX 95% RH
• Atmospheric pressure: 700 hPa – 1060 hPa

SYMBOLS ON THE DEVICE AND PACKAGING

• ON
• OFF
• • TYPE BF
• CLASS II
• ALTERNATING CURRENT
• ATTENTION
• ORDER NUMBER
• SN SERIAL NUMBER
• MANUFACTURER
• READ THE INSTRUCTIONS FOR USE
• European Community Directive 93/42/EEC
• Protected against solid foreign objects 12.5 mm in diameter and larger, and against drops of water
• European Authorised Representative
• Dispose of packaging in an environmentally friendly manner
• Permissible storage and transport temperature and humidity
• Permissible operating temperature and humidity
• CORRECT DISPOSAL OF THE PRODUCT
  (waste electrical & electronic equipment) (Applicable in the European Union and countries with separate collection systems). The symbol on the product/ documents indicates that the product complies with legislation on electrical and electronic equipment and it must not be disposed of as household waste.The user is responsible for taking the device to an appropriate waste disposal centre at the end of its service life, subject to administrative penalties and fines, provided for by the current legislation on waste. For more detailed information on available collection systems, refer to the local waste disposal service.
  The product contains a rechargeable battery covered by the European
  Directive 2006/66/EC, which cannot be disposed of as regular municipal waste. Please inform yourself about the local rules on separate collection of batteries.

WARRANTY

We provide a 5-year manufacturer’s warranty for this product from the date of purchase. The date of purchase must be proven by the receipt. Defects as a result of material or production faults will be remedied for free within the warranty period. The warranty claim does not extend the warranty period for the entire device, but only for the components that have been replaced. The warranty does not apply to wear and tear, transport damage and all damage resulting from improper handling (e.g. non-observance of the instructions for use) or caused by tampering by unauthorised persons. This warranty does not justify claims for damage against us. The purchaser’s statutory claims for defects in accordance with Art. 437 of the German Civil Code (BGB) are not restricted.

In the event of a warranty claim, the device must be sent together with the original proof of purchase to:

BOSCH + SOHN GMBH U. CO. KG
Bahnhofstr. 64, 72417 Jungingen,
GERMANY.

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