Vectura Akita JET, Instructions For Use Manual

Page 1: ...or 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...

Page 2: ...se 12 5 2 Cleaning 12 5 3 Disinfection 13 5 4 Storage Transporting 14 5 5 Cleaning AKITA JET Control Unit 14 5 6 Replacing Filter 14 6 Taking Treatment 16 6 1 Filling the Nebuliser 16 6 2 Connecting T...

Page 3: ...nty 31 11 Technical Data 32 11 1 General 32 11 2 Aerosol Characteristics 32 11 3 Operating Conditions 33 11 4 Storage and Transport Conditions 34 11 5 Service Life 34 11 6 Electromagnetic Compatibilit...

Page 4: ...onwards The system is not suitable for use in a healthcare environment with active HF Surgical Equipment and the RF shielded room of a system for magnetic resonance imaging where the intensity of ele...

Page 5: ...to its safe functioning in all cases when it is handled incorrectly It must be repaired only by Vectura or by a service depot expressly authorized by Vectura Only original AKITA JET accessories must...

Page 6: ...ogens e g multi resistant Staphylococci MRSA Burkholderia cepacia etc should always use only their own device and should inhale in a separate area from other patients Only use nebulisers which were cl...

Page 7: ...ies transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of thi...

Page 8: ...Use AKITA JET Year Pack Two AKITA JET nebuliser sets each set consisting of o Nebuliser nozzle attachment orange o Nebuliser tube o Help flow tube o Help flow adapter o Tubing clips Year Pack Instruct...

Page 9: ...the backside are not blocked 4 1 Connection of Power Supply and Power Cord Fig 1 Connect the power supply cable with the jack at the back of the control unit Fig 2 Connect the power supply with the po...

Page 10: ...ed off For additional information regarding the AKITA JET Smart Cards see Section 8 4 3 Nebuliser Assembly Assemble the AKITA JET nebuliser set as shown in the following illustrations Take care to pre...

Page 11: ...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: ...cian Please check the parts of your AKITA JET nebuliser regularly and replace any defective broken deformed or discoloured parts 5 1 Immediately after Use Immediately after each treatment all parts of...

Page 13: ...tion 5 3 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...

Page 14: ...the control unit For transporting you may pack the AKITA JET Inhalation System in the carrying case provided for this purpose Keep the nebuliser in a dry dust free place protected from contamination...

Page 15: ...garette 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 f...

Page 16: ...funnel max filling volume 8 ml Close the cap on the nebuliser upper section by clicking it into place WARNING Ensure that the medication level is not higher than the topmost mark on the scale If it ha...

Page 17: ...buliser 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 The nebuliser tube supplies the compressed...

Page 18: ...the Smart Card is correctly inserted see section 4 2 CAUTION Always ensure when operating the AKITA JET Inhalation System that the ventilation slots at the back of the control unit remains unobstructe...

Page 19: ...key The inhalation time is increased one step every time the key is pressed To decrease the inhalation time press the key until the first setting is shown The display shows the selected inhalation ti...

Page 20: ...set by the AKITA JET Inhalation System Try to inhale more slowly until the message inhale slowly no longer appears Do not block the mouthpiece with your tongue during inhalation Note how the AKITA JET...

Page 21: ...s the following message Inhale to continue last inhalation or cancel KEY You can now resume the last inhalation therapy simply by inhaling through the mouthpiece If you don t want to resume this inhal...

Page 22: ...n and disinfect the nebuliser now 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 s...

Page 23: ...gnized as effective e g in the list of tested and recognized disinfectants and procedures issued by the Robert Koch Institute DGHM and already validated in all cases If another procedure is used its e...

Page 24: ...erilised up to 300 times but then they must be replaced Even if the nebuliser has been sterilised fewer than 300 times it must still be replaced after one year s use Do not expose the nebuliser to tem...

Page 25: ...ion 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 nee...

Page 26: ...es that the medication is primarily deposited in the deep respiratory passages alveolar peripheral for the best therapeutic effect Medication aerosol is initially nebulised for every inspiration follo...

Page 27: ...nce Substance Dosage XXX mg in X ml Deposition Peripheral alveolar Inhalations 360 720 Inhalation time Number of breaths and volume total per breath 1 5 s 0 3 l XXX 2 0 s 0 4 l XXX 2 5 s 0 5 l XXX 3 0...

Page 28: ...AKITA JET 28 Substance Dosage X X s X X l XXXX breaths START INHALE or Substance Dosage X X s X X l Ready XXXX more breaths...

Page 29: ...though you have briefly sucked on the mouthpiece Ensure compliance with the following points The nebuliser is correctly assembled The help flow tube is connected via help flow adapter to the nebuliser...

Page 30: ...your doctor dealer If you have inserted a valid Smart Card ensure that the card is fitting correctly in the card slot Read the additional information in section 8 The AKITA JET switches off even thoug...

Page 31: ...in the device by parties not authorized to do so Compensation for direct or indirect damage or injury is excluded from the warranty Please ensure that you always operate the device with a filter Shou...

Page 32: ...ut 100 240 V 50 60 Hz 1 5 A Power Output 24 VDC 2 5 A Power Supply B Manufacturer XP Power GmbH Model AFM60US24C2 Power Input 100 240 V 50 60 Hz 1 5 A Power Output 24 VDC 2 5 A AKITA JET Nebuliser Min...

Page 33: ...16 4 5 2 08 36 4 37 6 35 0 36 6 4 3 30 62 0 62 8 60 3 62 9 3 5 39 82 1 82 6 80 5 83 1 2 8 61 93 8 94 0 93 2 94 3 1 14 1 100 0 100 0 100 0 100 0 11 3 Operating Conditions Ambient conditions under which...

Page 34: ...ect solar radiation Use the carrying handle provided when transporting the unit Do not store the nebuliser set control unit or power supply in damp areas e g bathroom or transport them together with d...

Page 35: ...floors are covered with synthetic material the relative humidity should be at least 30 15 kV air 15 kV air 3 V m 3 V m Guidance and Manufacturer s Declaration Electromagnetic Emission The AKITA JET ne...

Page 36: ...380 390 MHz 28 V m 430 470 MHz 50 PM at 18 Hz 28 V m 430 470 MHz 9 V m 704 787 MHz 50 PM at 217 Hz 9 V m 704 787 MHz 28 V m 800 960 MHz 50 PM at 18 Hz 28 V m 800 960 MHz 28 V m 1700 1990 MHz 50 PM at...

Page 37: ...ebuliser including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 6 where p is the maximum...

Page 38: ...applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NOTE 3 UT is the a c mains volta...

Page 39: ...g 2x AKITA JET nebuliser sets 1x filter 01VB0111 Nebuliser Set consisting of 1 nebuliser and 1 tube system 01VB0100 Tube System 01VB0103 AKITA JET Control Unit 01RS0100 AKITA JET Power Supply Type A 9...

Page 40: ...uary 27 2003 on waste electrical and electronic equipment and is included in product category 8 Medical devices for the purposes thereof Accordingly this product must not be disposed of with domestic...

Page 41: ...al 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 Tol...

Page 42: ...C Follow Instructions for Use Polarity Centre positive outer negative The AKITA JET is a Type BF equipment The AKITA JET is a protection class II appliance IP21 The Akita Jet is protected against ingr...