How to use the Nebulizer Mask
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:
- Star lumen/cavity design can effectively avoid the blockage of oxygen transfer
- Standard connector
- Peelable pouch, OEM design as per request
- 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 Ⅱa 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 belt（L2） | 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 |
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