Table of Contents
Advertisement
Quick Links
AKITA
JET Inhalation System Instructions for Use
®
WARNING:
Before using your AKITA JET Inhalation System, read and understand the entire Instructions
for Use. Save these Instructions for Use for future reference.
Patents:
EP 983103; US 6606989 / EP 1136093; DE 10013093 / US 7077125; CA 2386442
Additional Patents Pending
Manufacturer:
Vectura Group plc.
One Prospect West - Chippenham,
Wiltshire, SN14 6FH – United Kingdom
Email: info@akita-jet.com
Item Code 01DK0101 (DAW-00025 rev. 05)
Vectura Ireland Limited
The Brickhouse
Block 1, Clanwilliam Court
Lower Mount Street
Dublin, D02 CF97
Ireland
0123
Advertisement
Table of Contents
Summary of Contents for Vectura Akita JET
- Page 1 JET Inhalation System Instructions for Use ® WARNING: Before using your AKITA JET Inhalation System, read and understand the entire Instructions for Use. Save these Instructions for Use for future reference. Patents: EP 983103; US 6606989 / EP 1136093; DE 10013093 / US 7077125; CA 2386442...
-
Page 2: Table Of Contents
4 Assembling AKITA JET Inhalation System 4.1 Connection of Power Supply and Power Cord 4.2 Inserting Smart Card 4.3 Nebuliser Assembly 4.4 Installing Nebuliser Holder 5 Cleaning and Disinfecting AKITA JET Inhalation System 5.1 Immediately after Use 5.2 Cleaning 5.3 Disinfection 5.4 Storage, Transporting 5.5 Cleaning AKITA JET Control Unit... - Page 3 8 Smart Card 8.1 Important Instructions for the Smart Card 8.2 Medication-Specific Smart Cards 9 Troubleshooting 10 Warranty 11 Technical Data 11.1 General 11.2 Aerosol Characteristics 11.3 Operating Conditions 11.4 Storage- and Transport Conditions 11.5 Service Life 11.6 Electromagnetic Compatibility (EMC) 12 Accessories and Spare Parts 13 Recycling and Disposal 14 Service and Maintenance...
-
Page 4: Introduction
Instructions for Use. Intended Use The combination of an AKITA JET control unit and a nebuliser set from the AKITA JET Year Pack are intended for aerosol therapy of lower respiratory airways with inhalation solutions and suspensions. The system is suitable for use at home, hospital and general practice for temporary oral inhalation of inhalation solutions and suspensions prescribed or recommended by a physician. - Page 5 Accurate knowledge of and compliance with this Instructions for Use is required before the AKITA JET Inhalation System is used. The operator of the AKITA JET Inhalation System is liable to its safe functioning in all cases when it is handled incorrectly.
-
Page 6: Important Information For Your Safety
• Use the AKITA JET Inhalation System only when prescribed by a physician and only with the medication prescribed for the AKITA JET Inhalation System. Follow the dosage of your prescription. The use of other solutions and medications can lead to serious risks to health or can damage the device. - Page 7 Do not use AKITA JET Inhalation System in a ventilator circuit • Use the AKITA JET Inhalation System in a clean environment free from dirt, dust, pet hair, etc. • Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation.
-
Page 8: Getting Started
Year Pack Instructions for Use • Filter A complete AKITA JET Inhalation System ready for use consists of the AKITA JET control unit and an AKITA JET Year Pack. These parts are needed for correct functioning of the AKITA JET Inhalation System. -
Page 9: Assembling Akita Jet Inhalation System
CAUTION: • Make sure that the AKITA JET control unit is placed upright on a flat surface and that the air ventilation slots on the backside are not blocked. Connection of Power Supply and Power Cord Fig. -
Page 10: Nebuliser Assembly
Installing Nebuliser Holder In order to simplify handling, the AKITA JET control unit is equipped with a holder for the nebuliser. The nebuliser may be placed in the holder at any time. - Page 11 Fig. 5: Insert the nebuliser holder into the relevant slot at the back casing of the AKITA JET control unit. Fig. 6: Place the nebuliser in the nebuliser holder.
-
Page 12: Cleaning And Disinfecting Akita Jet Inhalation System
Cleaning and Disinfecting AKITA JET Inhalation System The AKITA JET nebuliser is intended for repeated use. When used in a home environment the nebuliser shall only be used by one single patient. To avoid any risk to health, e.g. infection from a contaminated nebuliser, it is essential to comply with the following hygiene rules: •... -
Page 13: Disinfection
• Continue with disinfection (see section 5.3). Disinfection The AKITA JET nebuliser must be disinfected once a day. Recommended Procedure: Steam disinfector (Baby bottle disinfector) • After cleaning the device according to the instructions above, place all components into the steam disinfector. -
Page 14: Storage, Transporting
Switch off the AKITA JET control unit and unplug the power cord from socket outlet each time before cleaning. • To clean the AKITA JET control unit wipe the exterior of the housing with a damp cloth, and if it is used by several patients also use a disinfecting cloth. •... - Page 15 • Change the filter more frequently if the air quality where the device is used is poor (such as from heavy cigarette smoking). • Replace the filter if it becomes wet or damp. To replace the filter: • Remove the filter cover from the back of the device and remove the used filter from the air inlet of the device (see figure below).
-
Page 16: Taking Treatment
To prevent under dosage always fill in the complete medication as provided within the ampoule. Connecting Tubes to the Nebuliser The AKITA JET Inhalation System operates with two tubes, which have different connectors so that they cannot be confused. -
Page 17: Connecting Tubes To The Control Unit
Connecting Tubes to the Control Unit The AKITA JET nebuliser is connected to the control unit via help flow tube and nebuliser tube. The help flow tube supplies you with a constant flow of air during inhalation. -
Page 18: Switching On Akita Jet Inhalation System
AKITA ® Finally attach the mouth piece to the nebuliser upper section. Your AKITA JET Inhalation System is now prepared for the treatment. CAUTION: • Check before every inhalation and during treatment, that the tubes are connected as shown in the following figure. -
Page 19: Setting Inhalation Time (Per Breath)
Your health care provider will usually determine the optimal inhalation time for you by a lung function test. The best way to test this is by a test inhalation with the AKITA JET Inhalation System with your health care provider. -
Page 20: Inhalation
AKITA JET Inhalation System will start. 2. While inhaling, let yourself be guided by the constant air flow of the AKITA JET. Avoid allowing the aerosol to escape through your nose during inhalation. Please note the information on the display. - Page 21 Disconnect the tubes from the nebuliser and leave the other side of the tubes connected to the AKITA JET control unit. Press any key to begin the drying cycle. At this point, the compressor will start running again to remove condensed water that may have collected in the tubes.
- Page 22 8. Wait 10 seconds, or press any key to show the residual drying time on the display: Drying system 120 seconds left 9. After the tubes have been dried the display will show: System dry Auto-power off 10. At this point, the AKITA JET Inhalation System will auto-power off. 11. Immediately continue with section 5.
-
Page 23: Additional Requirements For Multi Patient Use
CAUTION: • When the AKITA JET is used by multiple patients (e.g. in a hospital) it is essential to reduce the risk of cross contamination between patients. Therefore it is required to follow hygienic rules set out in the following subsections of the instructions for use. -
Page 24: Cleaning / Disinfect The Nebuliser
(TPE), Polyoxymethylene (POM). • In all cases, the aldehyde group of cleaning and disinfecting agents is suitable for cleaning and disinfecting the AKITA JET nebuliser. Recommended Procedure: Automated Washer / Disinfector • Place the nebuliser components in the instrument disinfector. -
Page 25: Sterilisation Of The Nebuliser
Add a suitable cleaner/ disinfectant and select the 60°C program. Sterilisation of the Nebuliser The AKITA JET control unit and the nebuliser are non-sterile products. Sterilisation process as described below is required in case of multi patient use. Sterilised parts do not need to be stored sterile or applied sterile to the patient. -
Page 26: Smart Card
Under dosage of a medication is only possible if the therapy was not completed. The display of the AKITA JET control unit keeps the patient informed of how many inhalations are still required to complete the therapy. -
Page 27: Medication-Specific Smart Cards
Medication-Specific Smart Cards Every medication Smart Card is specific to the active substance and dosage and provides the following information: Language indicator (e.g. English) XXXXX: Smart Card identification number Substance: Active substance Dosage: Dosage in active substance concentration per unit of volume Deposition: Inhalation pattern deposition Inhalation time and –volume:... - Page 28 AKITA ® Substance/Dosage Substance/Dosage X.X s - X.X l X.X s - X.X l XXXX breaths Ready XXXX more START>INHALE breaths...
-
Page 29: Troubleshooting
• the message “Error: Check The tube is not kinked connections” appears. The AKITA JET performs the Ensure compliance with the following points: • The nebuliser is correctly assembled self-test, but does not start • The help flow tube is connected via help flow adapter to the... - Page 30 AKITA JET for further 30 days with this card. • Please order a new Smart Card. • You can operate the AKITA JET for further 60 days without a card. The message “No card! • If you have no valid Smart Card available, you should order a new Inhalation another 60 days“...
-
Page 31: Warranty
Vectura or your service representative. Consumables are excluded from the warranty. The warranty period for the AKITA JET Inhalation System is 2 years starting from the date of purchase. -
Page 32: Technical Data
11.2 Aerosol Characteristics The particle size and output rate of the AKITA JET nebuliser (based on PARI LC SPRINT) was measured according to EN 13544:2007 Respiratory therapy equipment – Part 1: Nebulising systems and their components. The stated values may not be valid for medications with high viscosity or suspensions. In... -
Page 33: Operating Conditions
Aerosol Output: 0.75 ml Aerosol Output Rate: 0.23 ml/min Mass Median Aerodynamic Diameter MMAD: 3.8 µm Particle size distribution according to EN 13544-1 Cumulative Mass Distribution of a 2.5 % solution of sodium fluoride Cut-off Stage diameter [µm] Mean value Measurement 1 Measurement 2 Measurement 3... -
Page 34: Storage- And Transport Conditions
Nevertheless, electromagnetic interference can under certain conditions impair the device function. Interference can, for example, be caused by mobile telephones. If you detect such interference, switch off the AKITA JET and increase the distance from possible sources of interference (see also section 11.6). 11.4 Storage- and Transport Conditions Ambient conditions for transport and storage of the AKITA JET Inhalation System. -
Page 35: Electromagnetic Compatibility (Emc)
Electromagnetic Immunity Enclosure Port The AKITA JET nebuliser is intended for use in the electromagnetic environment specified below. The customer or the user of the AKITA JET nebuliser should assure that it is used in such an environment. IEC 60601-1-2:2014... - Page 36 AKITA ® Radio-frequency 80 MHz – 2.7 GHz 80 MHz – 2.7 GHz Mains power quality should be that of a EM fields and 80 % AM at 1 kHz typical home healthcare or hospital Proximity fields environment. 10 V/m 10 V/m from RF wireless 80 MHz –...
- Page 37 Electromagnetic Immunity AC Power Port The AKITA JET nebuliser is intended for use in the electromagnetic environment specified below. The customer or the user of the AKITA JET nebuliser should assure that it is used in such an environment Immunity test...
- Page 38 If the measured field strength in the location in which the AKITA JET nebuliser is used exceeds the applicable RF compliance level above, the AKITA JET nebuliser should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the AKITA JET nebuliser.
-
Page 39: Accessories And Spare Parts
12 Accessories and Spare Parts Use only approved spare parts. In particular, do NOT substitute other nebulisers for the AKITA JET nebuliser set. ESCRIPTION RTICLE AKITA JET Year Pack (comprising 2x AKITA JET nebuliser sets, 1x filter,) 01VB0111 Nebuliser Set (consisting of 1 nebuliser and 1 tube system) -
Page 40: Recycling And Disposal
AKITA ® 13 Recycling and Disposal This product falls within the scope of the European Council Directive on Waste Electrical and Electronic Equipment WEEE (Directive 2002/96/EC of the EUROPEAN PARLIAMENT AND THE EUROPEAN COUNCIL of January 27, 2003 on waste electrical and electronic equipment) and is included in product category 8: Medical devices for the purposes thereof. -
Page 41: Service And Maintenance
14 Service and Maintenance For repairs, claims under warranty or for disposal of equipment, please send the equipment to the following address: Vectura Group plc. One Prospect West - Chippenham Wiltshire SN14 6FH United Kingdom International telephone number: +49 (0) 89 897969 69... -
Page 42: Explanation Of Symbols Used
AKITA ® 15 Explanation of Symbols used The following symbols are used on the backside of the AKITA JET control unit, on the power supply or on the packaging: YMBOL EANING Manufacturer This device complies with the requirements of the Medical Devices Directive (93/42/EEC).