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M-neb Dose+ Instructions For Use Manual

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Instructions for use:
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M-neb
dose
mesh nebulizer MN-300/8

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Summary of Contents for M-neb Dose+

  • Page 1 Instructions for use: ® M-neb dose mesh nebulizer MN-300/8...
  • Page 2 - 2 -...
  • Page 3 NEBU-TEC med. Produkte Eike Kern GmbH Kreuzfeldring 17 63820 Elsenfeld – GERMANY 49) (0) 6022 – 610 62 0 Tel.: 49) (0) 6022 – 610 62 99 Fax: Email: info@nebu-tec.de Web: http://www.nebu-tec.de ® M-neb dose mesh nebulizer MN-300/8 Made in Germany - 3 -...

  • Page 4: Table Of Contents

    Maximum runtimes: ........................12 ® Delivery scope of the M-neb dose mesh nebulizer MN-300/8 ........... 13 ® The most important components of your M-neb dose mesh nebulizer MN-300/8 ..14 ® Start-up of the M-neb dose mesh nebulizer MN-300/8 ............15 ®...

  • Page 5: Icons

    Icons ® The icons are shown below that you see on your M-neb dose mesh nebulizer MN-300/8, the respective accessories and their packaging. Figure Definition Manufacturer; displays the manufacturer of the medical device. Caution; stresses the need for the user to review the instructions for use...
  • Page 6 Figure Definition DC connection Battery status indicator (Explanation on this in Chapter 11.0 Diode displays) Operating mode status indicator (Explanation on this in Chapter 11.0 Diode displays) On/off button Do not use if packaging is damaged; displays a medical product that should not be used if the packaging is damaged or opened.

  • Page 7: Safety Information

    Information, which prevents damage to the product. NOTE Information, which you should pay special attention to. NOTE ® Please carefully read through the instructions for use before first use of the M-neb dose mesh nebulizer MN-300/8. Store the instructions for use carefully. - 7 -...
  • Page 8 MN-300/X (type: GTM41076-0605-A) are visible. Protect the device and its accessories against uncontrolled access. ATTENTION ® An electrical device such as the M-neb dose mesh nebulizer MN-300/8 should never be operated unattended. Special caution is required if the device is used by or in the vicinity of children or seriously ill patients.
  • Page 9 USB cable with the USB connection of the M- ® dose mesh nebulizer MN-300/8 (control unit) (REF: 20100262). CAUTION ® Do not touch the aerosol generators in the M-neb dose nebulizer unit MN-300/8 ® (with the M-neb dose mouthpiece MN-300/8).
  • Page 10 In continuous mode, the maximum runtime is 1 hour. The maximum standby time (readiness to start the triggered mode) is 60 seconds. ® If the maximum runtime in the respective mode is reached, the M-neb dose mesh nebulizer MN-300/8 is switched off automatically.

  • Page 11: Intended Use

    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.

  • Page 12: Continuous Mode

    In continuous mode, the maximum runtime is 1 hour. The maximum standby time (readiness to start the triggered mode) is 60 seconds. ® If the maximum runtime is reached in the respective mode, the M-neb dose mesh nebulizer MN-300/8 is switched off automatically.

  • Page 13: Delivery Scope Of The M-Neb

    MN-300/8, please check the delivery scope for completeness. Also, check the delivered components for obvious, ® visible defects, impurities, cracks or damage. Never use the M-neb dose mesh nebulizer MN-300/8 or its components if they show visual defects or faults. In this case, contact the manufacturer or your dealer.

  • Page 14: The Most Important Components Of Your M-Neb Dose Mesh Nebulizer Mn-300/8

    ® The most important components of your M-neb dose mesh nebulizer MN- 300/8 ® Before you use your M-neb dose mesh nebulizer MN-300/8 for the first time, take some time to familiarise yourself with the device and the accessories. ®...

  • Page 15: Start-Up Of The M-Neb Dose Mesh Nebulizer Mn-300/8

    ® Start-up of the M-neb dose mesh nebulizer MN-300/8 ® Filling 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 cap back on and close with an 80° rotation in clockwise direction.

  • Page 16: Connect M-Neb ® Dose + Nebulizer Unit Mn-300/8 With The M-Neb

    ® ® Connect M-neb dose nebulizer unit MN-300/8 with the M-neb dose 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 of the control unit with the male USB connector of the nebulizer unit.

  • Page 17: Dose + Mesh Nebulizer Mn-300/8

    Start medication nebulisation and carry out inhalation ® 6.3.1 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 (control unit) switches on automatically. As indication, you will hear a short acoustic signal tone and the battery status indicator continuously lights up green.
  • Page 18 Please note that the maximum duration of an aerosol production phase is 1.5 seconds. ® 6.3.5 Do not exhale through the mouthpiece of the M-neb dose mesh nebulizer MN- 300/8. Put it down to exhale.

  • Page 19: Switch Off M-Neb

    Switch off M-neb dose mesh nebulizer MN-300/8 ® In order to stop or pause the nebulizer before it is finished, the M-neb dose mesh nebulizer MN-300/8 must be switched off. Press (> 1 second) the on/off button of the M- ®...

  • Page 20: Changing The Operating Modes

    ® 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 ® (control unit). The M-neb dose mesh nebulizer MN-300/8 switches on automatically.
  • Page 21 60 seconds, which is equivalent to the maximum standby time. ® 6.5.5 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 ®...

  • Page 22: Use Of The Continuous Mode

    M-neb dose mesh nebulizer MN-300/8 has been placed in operational readiness. To do this, proceed as follows: ® 6.6.1 Press (> 1 second) the on/off button of the M-neb dose mesh nebulizer MN-300/8 ® (control unit). The M-neb...

  • Page 23: Power Supply

    If the capacity is less than the limit of 10 %, the battery status indicator lights up ® continuously red. The M-neb dose mesh nebulizer MN-300/8 switches off automatically. ® If the capacity has reached the limit of 10%, the battery of the M-neb dose mesh nebulizer MN-300/8 must be charged. - 23 -...
  • Page 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). - 24 -...
  • Page 25 ® 8.0.2 Then connect the M-neb power cord MN-300/X (type: GTM41076-0605-A) with the 230 VAC power supply. 8.0.3 The charging of the battery starts now. ® 8.0.4 If the M-neb dose mesh nebulizer MN-300/8 3 is charging, the battery indicator light flashes green (ratio: 1 second green/1 second pause).
  • Page 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). - 26 -...

  • Page 27: Cleaning

    NOTE ® The charging time for the internal, rechargeable battery (lithium ion battery) of the M-neb dose mesh nebulizer MN-300/8 is approx. 3 hours for 100% charging capacity depending on the initial state. CAUTION ® To avoid damage to the M-neb...

  • Page 28: Dose + Mouthpiece Mn

    60 seconds, which is equivalent to the maximum ® standby 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 lights up continuously blue.

  • Page 29: Diode Displays

    - continuously blue if the RF power amplifier is enabled (power indicator). 12.0 Ambient conditions ® The environmental conditions of the M-neb dose mesh nebulizer MN-300/8 are listed in the following chapters which are required for the proper functioning in accordance with the intended use of this device.

  • Page 30: Duration Of Use

    (Waste Electrical and Electronic Equipment Act - ElektroG) and is classified 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...

  • Page 31: Technical Specifications

    MN-300/8 (Item no. 20100268) The aerosol dispensing according to DIN EN 13544-1/Annex CC - CC.1.4 is 1.17 +/- 0.04 ® mg sodium chloride per minute when using the M-neb dose nebulizer unit MN-300/8 (Item no. 20100268). The aerosol dispensing according to DIN EN 13544-1/Annex CC - CC.2 is 1.86 mg sodium ®...

  • Page 32: Aerosol Spectrum

    The particle size of the M-neb dose mesh nebulizer MN-300/8 according to DIN EN ® 13544-1/Annex CC is on average 3.68 µm MMD at a GSD of 1.64 when using the M-neb dose nebulizer unit MN-300/8 (Item no. 20100268). 18.0 Accessories/Ordering information ®...

  • Page 33: Information On Electromagnetic Compatibility

    Complies fluctuations/flicker according to IEC 61000-3-3 WARNING ® The M-neb dose mesh nebulizer MN-300/8 may not be placed directly next to other devices. If necessary, the device should be observed to verify its proper operation in the configuration used. Guidelines and manufacturer’s declaration – Electromagnetic immunity The nebulizer MN-300/8 is intended for use in the ELECTROMAGNETIC ENVIRONMENT specified below.
  • Page 34 Guidelines and manufacturer’s declaration – Electromagnetic immunity The nebulizer MN-300/8 is intended for use in the ELECTROMAGNETIC ENVIRONMENT specified below. The customer or the user of the nebulizer MN-300/8 should ensure that it is used in such an environment. IEC 60601 test level Electromagnetic environment guidelines Immunity tests Compliance level...
  • Page 35 Recommended safe distances between portable and mobile RF telecommunications equipment and the nebulizer MN-300/8 The nebulizer MN-300/8 is intended for use in an electromagnetic environment in which the RF disturbances are controlled. The customer or the user of the nebulizer MN-300/8 can help prevent electromagnetic interference by adhering to the minimum distance between portable and mobile RF telecommunications equipment (transmitters) and the nebulizer MN-300/8 - depending on the output power of the communications equipment, as specified below.

  • Page 36: Ec Certificate Of Conformity

    HD 60101825 0001 CE mark since 2016 23.0 Warranty ® We grant you a warranty of 24 months from the date of purchase on your M-neb dose mesh nebulizer MN-300/8. ® We can grant you this warranty on the M-neb...
  • Page 37 Your notes: ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. ……………………………………………………………………………………………………….. - 37 -...
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  • Page 40 NEBU-TEC med. Produkte Eike Kern GmbH Kreuzfeldring 17 / 63820 Elsenfeld - Germany...

This manual is also suitable for:

Mn-300/8

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