background image

- 11 - 

 

3.0 

Intended use 

The M-neb

® 

dose

+

 mesh nebulizer MN-300/8 is a medication nebulizer which is intended 

to bring medication in the form of a precise dose even into the smallest air passages of the 
lungs. 
 
The M-neb

®

 dose

+

 mesh nebulizer MN-300/8 provides aerosol doses for inhalation using 

the  mouthpiece.  Aerosol  production  is  triggered  by  breathing  through  the  mouthpiece 
(triggered mode). The maximum length of a single aerosol production phase is 1.5 seconds 
(triggered mode). The production of the aerosol dose may be affected by the duration of 
the inhalation session (triggered mode). 
 
The selection of the medication, which is used for the generation of the aerosols by the M-
neb

® 

dose

+

 mesh nebulizer MN-300/8, may only be made by the physician. 

 
The selected medication must be approved for this type of application (inhalation on the 
principle of mesh nebulisation) by the (pharmaceutical) manufacturers. 
 
 

3.1 

Functional description of the M-neb

®

 dose

+

 mesh nebulizer MN-300/8 

 
The  M-neb

® 

dose

+

  mesh  nebulizer  MN-300/8  has  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 MN-300/8 3 is indicated by 

the signalling of the blue LED of the operating mode status indicator as well as the blue 
lighting  up  of  the  M-neb

®

  dose

+

  nebulizer  unit  MN-300/8  (with  the  M-neb

®

  dose

+

 

mouthpiece MN-300/8). 
 
 

3.2 

Nebulizer modes 

The respective nebulisation modes of the device M-neb

®

 dose

+

 mesh nebulizer MN-300/8 

are explained in this chapter. 

 
 
3.2.1  Triggered mode 

 
In  the  triggered  mode,  the  aerosol  production  is  triggered  by  breathing  through  the 
mouthpiece. The M-neb

®

 dose

+

 mesh nebulizer MN-300/8 only produces aerosol during 

the inhalation phase (synchronisation).  
In the triggered mode, the operating mode status display LED and the nebulizer unit light 
up for the duration of the inhalation with each phase of the aerosol production. 
The maximum duration of an aerosol production phase is 1.5 seconds. 
The  production  of  the  aerosol  dose  may  be  affected  by  the  duration  of  the  inhalation 
session. 
The triggered mode is set as the default at the factory for the M-neb

®

 dose

+

 mesh nebulizer 

MN-300/8 device. 
 
 

 

Содержание Dose+

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

Страница 2: ...2...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 37: ...37 Your notes...

Страница 38: ...38...

Страница 39: ...39...

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

Отзывы: