M-neb Dose+, Instructions For Use Manual

Page 1: ...ultrasonic nebulizer Instructions for use M neb dose mesh nebulizer MN 300 8...

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Page 3: ...TEC med Produkte Eike Kern GmbH Kreuzfeldring 17 63820 Elsenfeld GERMANY Tel 49 0 6022 610 62 0 Fax 49 0 6022 610 62 99 Email info nebu tec de Web http www nebu tec de M neb dose mesh nebulizer MN 30...

Page 4: ...out inhalation 17 6 4 Switch off M neb dose mesh nebulizer MN 300 8 19 6 5 Changing the operating modes 20 6 6 Use of the continuous mode 22 7 0 Power supply 23 8 0 Charging of the M neb mesh nebuliz...

Page 5: ...Device of protection class II Type B applied part 0197 CE mark including designation of the identification number of the notified body which has performed the conformity assessment procedure Follow in...

Page 6: ...is damaged or opened Keep away from sunlight designates a medical device that needs protection from light sources Store in a dry place designates a medical device that must be protected against moistu...

Page 7: ...Important information is highlighted by the following expressions WARNING Important safety information on hazards that can cause personal injury ATTENTION Important information on operation steps that...

Page 8: ...bserved to verify its proper operation in the configuration used 15 Do not open the housing All repairs or maintenance may only be done by a dealer qualified by NEBU TEC med Produkte Eike Kern GmbH Fa...

Page 9: ...se any other commercially available USB cable with the USB connection of the M neb dose mesh nebulizer MN 300 8 control unit REF 20100262 CAUTION 1 Do not touch the aerosol generators in the M neb dos...

Page 10: ...vices without implantable and infectious products Therefore the electronic components of the M neb dose mesh nebulizer MN 300 8 M neb dose mesh nebulizer MN 300 8 control unit and M neb power cord MN...

Page 11: ...s two modes of nebulisation triggered mode and continuous mode The basic setting of the M neb dose mesh nebulizer MN 300 8 is the triggered mode Any aerosol production of the M neb dose mesh nebulizer...

Page 12: ...nuous mode is selected in the following chapter 6 5 Changing the operating modes 3 3 Automatic switch off Regardless of the nebulisation mode the M neb dose mesh nebulizer MN 300 8 switches off automa...

Page 13: ...M41076 0605 A 2 pc 20100268 M neb dose nebulizer unit MN 300 8 incl M neb dose mouthpiece MN 300 8 1 pc 20100207 M neb Etui MN 300 X NOTE Before the first use of the M neb dose mesh nebulizer MN 300 8...

Page 14: ...the accessories All components of the M neb dose mesh nebulizer MN 300 8 are listed in the table below Number Designation Figure 20100262 M neb dose mesh nebulizer MN 300 8 control unit 20100206 M neb...

Page 15: ...illing the M neb dose nebulizer unit MN 300 8 6 1 1 Open screw cap using an 80 rotation counter clockwise then lift the cap upwards 6 1 2 Pour medication into the medication chamber 6 1 3 Place screw...

Page 16: ...mesh nebulizer MN 300 8 control unit After this connect the filled M neb dose nebulizer unit MN 300 8 with the M neb dose mesh nebulizer MN 300 8 control unit To do this connect the female USB socket...

Page 17: ...green 6 3 2 The operational readiness of the M neb dose mesh nebulizer MN 300 8 is established after the operating mode status indicator has flashed three times blue briefly 6 3 3 The M neb dose mesh...

Page 18: ...around the mouthpiece of the M neb dose mesh nebulizer MN 300 8 3 again and inhale through your mouth To exhale put down the mouthpiece of the M neb dose mesh nebulizer MN 300 8 again and do not exha...

Page 19: ...d the M neb dose mesh nebulizer MN 300 8 must be switched off Press 1 second the on off button of the M neb dose mesh nebulizer MN 300 8 control unit The M neb dose mesh nebulizer MN 300 8 switches of...

Page 20: ...eadiness of the M neb dose mesh nebulizer MN 300 8 is not established and the device is in the switched off state 6 5 1 Press 1 second the on off button of the M neb dose mesh nebulizer MN 300 8 contr...

Page 21: ...ator lights up again three times briefly 6 5 7 In order to switch off the M neb dose mesh nebulizer MN 300 8 press 1 second the on off button of the M neb dose mesh nebulizer MN 300 8 control unit A s...

Page 22: ...The M neb dose mesh nebulizer MN 300 8 switches on automatically As indication you will hear a short acoustic signal tone and the battery status indicator continuously lights up green 6 6 2 The operat...

Page 23: ...control unit may only be charged via the M neb power cord MN 300 X type GTM41076 0605 A The M neb dose mesh nebulizer MN 300 8 control unit may only be operated via the M neb power cord MN 300 X type...

Page 24: ...24 8 0 1 Connect the supplied M neb power cord MN 300 X type GTM41076 0605 A for charging first with the M neb dose mesh nebulizer MN 300 8 control unit...

Page 25: ...8 3 is charging the battery indicator light flashes green ratio 1 second green 1 second pause 8 0 5 If the M neb dose mesh nebulizer MN 300 8 has completed charging the battery indicator light flashes...

Page 26: ...26 ATTENTION The charging of the internal rechargeable battery lithium ion battery is carried out exclusively with the supplied M neb power cord MN 300 X type GTM41076 0605 A...

Page 27: ...dose mesh nebulizer MN 300 8 ensure that the M neb power cord MN 300 X type GTM41076 0605 A has been disconnected Never immerse the housing of the M neb dose mesh nebulizer MN 300 8 in water or a cle...

Page 28: ...ndby time For this press 1 second the on off button of the M neb dose mesh nebulizer MN 300 8 control unit Two consecutive short acoustic signal tones sound and the operating mode status indicator lig...

Page 29: ...ot lit when charging is completed Operating mode status indicator The operating mode status indicator LED blue lights blue three times briefly when the boot phase is terminated blue once briefly when...

Page 30: ...ied in the category 8 medical devices without implantable and infectious products Therefore the electronic components of the M neb dose mesh nebulizer MN 300 8 M neb dose mesh nebulizer MN 300 8 contr...

Page 31: ...ata Aerosol dispensing and particle size in accordance with DIN EN 13544 1 Annex CC were determined and established for the M neb dose mesh nebulizer MN 300 8 16 1 Performance data of the M neb dose m...

Page 32: ...m the manufacturer or dealer for your M neb dose mesh nebulizer MN 300 8 Item number Designation Quantity 20100008 M neb dose Starter Kit MN 300 8 1 pc 20100104 M neb dose consumption material for a p...

Page 33: ...t it is used in such an environment Immunity tests IEC 60601 test level Compliance level Electromagnetic environment guidelines ELECTROSTATIC DISCHARGE ESD according to IEC 61000 4 2 6 kV contact disc...

Page 34: ...Veff D 1 2 P Radiated RF disturbance according to IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m D 1 2 P 80 MHz to 800 MHz D 2 3 P 800 MHz to 2 5 GHz Where P is the rated output of the transmitter in wat...

Page 35: ...ansmitter W Safety distance dependent on transmission frequency 150 kHz to 80 MHz D 1 2 P 80 MHz to 800 MHz D 1 2 P 800 MHz to 2 5 GHz D 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3...

Page 36: ...LGA Products GmbH Tillystra e 2 90431 N rnberg Germany ID 0197 Conformity assessment procedure EC Directive 93 42 EEC Annex II Section 3 EC certificate HD 60101825 0001 CE mark since 2016 23 0 Warrant...

Page 37: ...37 Your notes...

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Page 40: ...NEBU TEC med Produkte Eike Kern GmbH Kreuzfeldring 17 63820 Elsenfeld Germany...