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How to use the Nebulizer Mask

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ZRMED is professional nebulizer mask, oxygen mask, nasal oxygen cannula manufacturer, welcome to inquiry.

Nebulizer mask's accessories

The Nebulizer with aerosol masks, is made from PVC, PP, PC and PE in medical grade, consists of mask, nebulizer, oxygen tube, elastic belt, aluminium flake and connector. The Nebulizer with aerosol masks has the following features:

 

  1. Star lumen/cavity design can effectively avoid the blockage of oxygen transfer
  2. Standard connector
  3. Peelable pouch, OEM design as per request
  4. Sterile by EO, single use

 

Table of Variants

Type Size
Aerosol mask with Nebulizer, 6ml Adult standard, Pediatric standard, Adult elongated, Pediatric elongated
Aerosol mask with Nebulizer, 8ml Adult standard, Pediatric standard, Adult elongated, Pediatric elongated

 

2. The purpose and functions of the product and its variants and their design

Intended Use: the Nebulizer with aerosol masks is used to administer medication to people in the form of a mist inhaled into the lungs.

 

To achieve above-mentioned purpose, the product should have the following functions: medicine solution nebulization.

 

Medicine solution nebulization 

The Nebulizer with aerosol masks has the standard connector which allows the Nebulizer with aerosol masks to be connected to a compressed air source that causes air or oxygen to blast at high velocity through a liquid medicine to turn it into an aerosol.

 

3. Classification according to Annex IX of Council Directive 93/42/EEC

The Nebulizer with aerosol masks is non-invasive device. The device is intended for short-term use. According to rule 2 of Annex IX, III of Council Directive 93/42/EEC (2007), the Nebulizer with aerosol masks belong to class a medical devices.

 

4. Main technical parameters of the product

4.1 Material

Material for Nebulizer with aerosol masks as follows:

 

Nebulizer with aerosol masks with 8ml nebulizer

Sequence# Component Material used
1 Mask PVC
2 Mask connector PVC
3 Oxygen tube PVC
4 Oxygen connector PVC
5 Jar PP
6 Jet tube PP
7 Cap PP
8 Aluminium flake Aluminium
9 Elastic belt /

Nebulizer with aerosol masks with 6ml nebulizer

Sequence# Component Material used
1 Mask PVC
2 Mask connector PVC
3 Oxygen tube PVC
4 Oxygen connector PVC
5 Jar PC
6 Upper cap PP
7 Middle cap PP
8 Aluminium flake Aluminium
9 Elastic belt /

 

4.2 Physical requirements

4.2.1 Measures

Table 1: Dimensions of Nebulizer with aerosol masks

Type L W H Elastic beltL2 Oxygen tube
L1 φ1 φ2
Adult standard 105mm±5mm 85mm±3mm 60mm±3mm 500mm±10mm 2130mm±50mm 5.6mm±0.1mm 3.0±0.2mm
Pediatric standard 75mm±5mm 70mm±3mm 45mm±3mm
Adult elongated 130mm±5mm 85mm±3mm 65mm±3mm
Pediatric elongated 95mm±5mm 70mm±3mm 50mm±3mm

4.2.2 Physical tests

Physical tests are performed to the Nebulizer with aerosol masks in accordance with YZB/ 0010:2003 & YZB/0491-2005.

 

4.3 Chemical & Biological requirements

The Nebulizer with aerosol masks are sterilized by ETO in accordance with ISO11135:2007, the index of the biological compatibility conforms to ISO-10993-1:2009.

Sequence # Biocompatibility tests performed Results
1 Cytotoxicity Comply with ISO10993-5
2 Sensitization Comply with ISO10993-10
3 Irritation Comply with ISO10993-10
4 EO residue Comply with ISO10993-7

 

Welcome to inquiry.

 

Email: info@zrmed.com

Skype:alex-zmc

What’s app: +8613675828474

We Chat: +8613675828474

 

 

 

 

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