Kinetik Wellbeing NE803 Instruction manual

Compressor Nebuliser
MODEL No.:NE803
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Please keep this instruction manual safe for your future use.
Please use only USB 5V/1A which complies with the standard of
IEC 60601-1,which provide 2 MOPP.
Limit use to 15 minutes at a time, and allow a 40 minutes
interval before using the device again.
Table of Contents
Before using the device
1. Introduction
2. Indications for Use ....................................................................1
3. Symbols ....................................................................................2
4. Important safety notes / Return Policy ................................3-6
5. Know your device
6. Guide to using the Compressor Nebuliser ...........................9
Operating instructions
7. Preparing the nebuliser for use ......................................10-13
8. Taking medication ..........................................................14-16
Care and maintenance
9. Cleaning and daily disinfecting
9.1 .............................................................................17
Cleaning
9.2 Disinfecting the nebulising parts ....................................18
10. Maintenance and storage ....................................................20
11. Changing the air filter............................................................21
others
12. Troubleshooting
13. Technical data
...............................................................................1
...............................................................7-8
.....................................17-19
..................................................................22
................................................................23-24
14. EMC Table........................................................................25-27
15. Optional parts and accessories ..........................................28
1. Introduction
Thank you for purchasing our Compressor Nebuliser.
The Device includes a nebuliser kit, an air tube, an instruction manual, a compressor with an air pump that generates compressed air, a mouthpiece and masks (adult & child). The nebuliser kit converts the liquid medication into a fine aerosol which is inhaled by the patient via a mouthpiece for the treatment of respiratory disorders.
The Compressor Nebuliser is a medical device. Operate the device only as instructed by your doctor and/or respiratory therapist.
■ The device fulfils the provisions of the EC directive 93/42/EEC (Medical Device Directive) and the European Standard EN13544-1:2007, Respiratory therapy equipment ­Part1: Nebulising systems and their components.
2. Indications for Use
Intended Use The device is intended to be used for spraying liquids in aerosol form into
Intended User Legally certified medical experts,such as doctor, nurse and therapist, or
healthcare personnel or patient under the guidance of qualified medical experts for the home treatment. The user should also be capable of understanding general machine operation and the content of instruction manual.
Intended Patients The device should not be used by patients who are unconscious or are
not breathing spontaneously.
Environment The device is intended for use in a medical facility and general household.
Durable Period
Precautions for use Warnings and cautions described in the instruction manual
should be observed.
gases that are delivered directly to the patient for breathing.
Durable periods are as follows, provided the device is used to nebulize 2 ml of medication twice a day for 7.5 minutes each time at room temperature (23°C). Durable period may vary depending on usage environment. Frequent use of the device may shorten the durable period. Compressor (Main unit) 2 years Nebulizer Kit 1 year Mouthpiece 1 year Air Tube (PVC, 100cm)/Mask 1 year Air Filter 60 days
EN
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3. Symbols Use
SYMBOLS USED IN THIS INSTRUCTION MANUAL
WARNING
CAUTION
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property.
Transport package shall be kept away from rain.
AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY
Refer to instruction manual/booklet
The marking of electrical and electronics devices according to Directive 2002/96/EC. The device,accessories and the packaging have to be disposed of correctly at the end of the usage. Please follow Local Ordinances or Regulations for disposal.
MANUFACTURER
SERIAL NUMBER
Type BF applied part
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4. Important Safety Notes
Read all the information in the instruction manual and any other literature included in the box before using the device. To ensure the correct use of the device, basic safety notes should always be followed including the precautions listed below:
Warning:
Indicate a potentially hazardous situation which, if not avoided, could result in
serious injury.
(Usage)
• For type, dose, and regime of medication, follow the instructions of your doctor or respiratory therapist.
• Do not use water in the nebuliser, for nebulising purposes.
• If you feel anything unusual during use, stop using the device immediately and consult your doctor.
• Do not use the device where it may be exposed to flammable gas.
• Make sure that the nebuliser kit is clean before use.
• Do not operate the device in the presence of any anaesthetic, inflammable mixtures or oxygen.
• Clean and disinfect the nebuliser kit, mouthpiece or mask before using them for the first time after purchase, if the device has not been used for a long period of time, or if more than one person uses the same device.
• Be sure to wash the nebuliser kit, mouthpiece or mask after every use, and ensure that they are thoroughly disinfected and dried, and stored in a clean location.
• Keep the device out of the reach of unsupervised infants and children. The device may contain small pieces that can be swallowed.
• Store the device and accessories in a clean location.
• Do not store the air tube while there is moisture or medication remaining inside it.
• Always rinse the nebulising parts with clean boiled water after disinfecting them. Never leave the cleaning solution in the medication tank or mouthpiece.
• Do not use or store the device where it may be exposed to noxious fumes or volatile substances.
• Do not cover the compressor nebuliser with a blanket or towel etc, during use.
• Always dispose of any remaining medication after use, and use fresh medication each time.
• Do not use in anaesthetic or ventilator breathing circuits.
• Any components, if damaged and not user serviceable, need to be repaired by qualified service personnel.
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4. Important Safety Notes -1
(Risk of electrical shock)
• The compressor nebuliser is not waterproof. Do not spill water, or other liquids on these parts. If liquid does spill on these parts, immediately unplug the USB and wipe off the liquid with gauze or other absorbent material.
• Do not immerse the compressor (main unit) in water or other liquid.
• Do not use or store the device in humid locations, such as a bathroom.
• USB must comply with the standard of IEC 60601-1, which provide 2 MOPP.
(Cleaning and disinfecting)
Observe the rules below when cleaning or disinfecting parts. Failure to observe these rules may result in damage, inefficient nebulisation or infection. For the instructions, refer to “Cleaning and disinfecting” section.
• Clean and disinfect the nebuliser kit, mask, or mouthpiece before using them when as follows:
--the first time after purchase.
--the device has not been used for a long period of time.
--more than one person uses the same device.
• Be sure to wash or wipe the parts after use, and ensure that they are thoroughly disinfected and dried, and stored in a clean location.
• Do not leave the cleaning solution in the parts.
Caution
Indicate a potentially hazardous situation which, if not avoided, may result in minor or moderate injury, or physical damage.
• Provide close supervision when the device is used by, on, or near children and the physically incapable.
• Make sure that the parts are attached correctly.
• Make sure that the air filter is correctly attached.
• Make sure that the air filter is clean. If the air filter has changed colour, or has been used on average for more than 60 days, replace it with a new one.
• Do not spill liquid or medication on the compressor.
• Do not tilt the nebuliser kit at an angle of greater than 45 degrees in all directions, or shake it while in use.
• Do not use or store the device while the air tube is creased.
• Use only original nebulising parts, air tube, air filter and air filter cover.
• Do not add more than 10 ml of medication to the medication tank.
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4. Important Safety Notes -2
• Do not carry or leave the nebuliser kit while the medication tank contains medication.
• Do not leave the device unattended with infants or persons that cannot express their consent.
• Do not subject the device or the parts to any strong shocks such as dropping the device on the floor.
• Do not distort the vaporiser head, or jab the nozzle of the medication tank with a pin.
• Do not disassemble or attempt to repair the compressor nebuliser.
• Do not block the air filter cover.
• When sterilising the parts by boiling, make sure that the container does not get to such a temperature that the water evaporates.
• Do not leave the device in extreme hot or cold temperature, or under direct sunlight.
• Do not use the device while sleeping or if drowsy.
• The compressor may become hot during operation.
• Limit use to 15 minutes at a time, and allow a 40 minutes interval before using the device again.
• Do not touch the compressor for other than necessary operation such as turning off the power while nebulising.
• To avoid the medication residue on the face, be sure to wipe the face after removing the mask.
• Do not use a damaged nebuliser kit, or mouthpiece.
• Do not block the slit between the cap and the inhalation air inlet.
• Do not use a microwave oven or hair dryer to dry the device or the parts.
• Approved for human use only.
(Risk of electrical shock)
• Always remove the batteries and unplug the USB power cable after use and before cleaning.
• Changes or modifications will void the user warranty.
• When an external USB power supply is used in the device, such as an ME system, only use a USB that complies with the standard of IEC 60601-1, which provide 2 MOPP.
(Cleaning and disinfecting)
Observe the rules below when cleaning or disinfecting parts. Failure to observe these rules may result in damage, inefficient nebulisation or infection. For the instructions, refer to “Cleaning and disinfecting” section.
• Do not use a microwave oven, dish dryer or hair dryer to dry the device or the parts.
• Do not use an autoclave, EOG gas steriliser or low temperature plasma steriliser.
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4. Important Safety Notes -3
• When disinfecting the parts by boiling, make sure that the container does not get to such a temperature that the water evaporates. Otherwise it may result in fire.
General Safety Precautions:
• Inspect the device and the parts before using them each time, and check that there are no problems. In particular, be sure to check the following:
- That the vaporiser head, nozzle or air tube are not damaged.
- That the nozzle is not blocked.
- That the compressor operates normally.
•When using the device, there will be some noise and vibration caused by the pump in the compressor. There will also be some noise caused by the emission of compressed air from the nebuliser kit, which is normal and does not indicate a malfunction.
• Operate the device only as intended. Do not use the device for any other purpose.
• Do not use the device at temperatures out of +5°C to +40°C.
• Make sure that the air tube is securely attached to the compressor (main unit) and the nebuliser kit and does not come loose. Twist the air tube plug slightly when inserting it into the connector to avoid the tube disconnecting during use.
• Remove the batteries if the unit will not be used for 3 months or longer.
Return Policy
Product may be returned if faulty, please contact the Retailer or Kinetik directly if you’re experiencing issues with your product. This does not affect your statutory rights. Please note the retailer’s own return policy may still be valid, contact the retailer for more information.
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Nebuliser Kit Holder
Air Tube Connector
Battery Cover
5. Know your device
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Indicator Light
Power Switch
Air Filter Cover *Air Filter Inside
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USB Power Connector
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(PVC ǃ100cm)
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Nebuliser Kit x1
Inhalation Top
5. Know your device -1
Cap
Vaporiser Head
Medication Tank
Nozzle
Accessories
Adult Mask (PVC) Child Mask (PVC)
(Option )
Material of attachment
Air tube/Mask: PVC Air Filter: Polyester
Mouthpiece: PP
• Also applicable Section : Optional parts and accessories
Mouthpiece x1
Air Tube (PVC, 100cm)
Air Tube Connector
Spare Air Filters x 5
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