Wuyishan Jiean Medical Devices Manufacturing Co.,Ltd
We are professional supplier of New Combined Spinal Epidural Anesthesia kit AS-E/S .
Business Type:Manufacturer
Country/Region:China
Ddu Verified
HOT Rank
Type
This product includes 3 types: TYPE I, TYPE II, TYPE IIR, according to EN14683:2019 section 5.2.7 Summary of performance requirements, description of each kind refer to table 1 Performance table.
Test | Type I a | Type Ⅱ | Type IIR |
Bacterial filtration efficiency(BFE), (% ) | ≥95 | ≥98 | ≥98 |
Differential pressure (Pa/cm2) | <40 | <40 | <60 |
Splash resistance pressure(kPa) | Not required | Not required | ≥16.0 |
Microbial cleanliness (cfu/g) | ≤30 | ≤30 | ≤30 |
Table 1 Performance table
1.2.2 Model: Ear-loop type/ Flat strap type
Ear-loop type Flat strap type
1.2.3 Specification
Specification | Large | Medium | Small |
Size (allowance:±5%) | 17.8x9.5cm | 17x9cm | 15x9cm |
1.3 Component
The product consists of a face piece, a nose clip and a mask band or ties. The face piece has 3 layers: an inner and outer layer of spun bond non-woven fabric and a middle layer of melt-blown non-woven fabric.
1.4 Intended use
It is intended to limit the transmission of infective agents from staff to patients during surgical procedures and other medical settings with similar requirements and reducing the emission of infective agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms.
1.5 List of material
Part name | Material | |
Face Piece | Inner layer | PP Non-Woven fabric (Direct contact)
|
Outer layer | PP Non-Woven fabric
| |
Middle layer | PP Melt-blown fabric
| |
Ear band | Spandex(ear-loop type) or PP(flat strap type ) | |
Nose clip | Iron or plastic | |
Package | ||
Carton | Carton | |
Inner box | Ivory board | |
Inner bag | Paper-Poly Pouch | |
1.6 Instruction for Use
1). Open the package, take out the mask, hold the two ends of the mask with the nose bridge facing upwords.
2). Cover the nose and jaw with the mask, and put the ear band behind the ear.
3). Adjust the nose band to fit the bridge of the nose to achieve a tight seal.
4). Properly adjust the position of the mask to make it comfortable to wear, Wear it correctly according to the color. The white is inside and blue is Outside and do not touch the inside of the mask with your hands.
5). Discard mask after use according to local discard regulatory and be aware not to touch the outside of the mask with your hands
1.7 Contraindication
People who are allergic to this product should not use.
1.8 Warning and cautions
1). Please read the instructions carefully before use to avoid touching the inner layer of the mask with your hands;
2). Please check package, if the package is damaged, it is forbidden to use it;
3). This product is single patient use and should not be reused;
4). In case of liquid splashing, mask damage, moisture and significant increase in respiratory resistance during wearing, please replace it immediately;
5). After using the product, it should be disposed of according to the requirements of the hospital or environmental protection department.
1.9 Transportation and Storage method
The product should be stored in a cool, dry, corrosive gas free, well-ventilated and clean environment.
1.10 Shelf Life
24 months
